All pages on pdufa.bio
Page updated ·next FDA decision on the calendar ·Data as of Nov 12, 2026 2:24 AM ET Every page in the sitemap, 1685 in all, grouped by section, each under its own title. The XML sitemap carries the same list for crawlers.
Site · 93
- PDUFA Dates 2026: FDA Decision Calendar, Updated Daily
- About pdufa.bio: who we are, what we refuse to publish
- FDA Advisory Committee Meetings 2020-2026: 187 Federal Register Notices, 2 Votes
- CAPR FDA AdComm Jul 29, 2026: Panel votes 3-9 against Deramiocel (CAP-1002)
- REPL FDA AdComm Jul 30, 2026: Panel votes 10-3 favorable on RP1 (vusolimogene)
- Clinical Trial Success Rates by Phase
- 2026 Biotech Conference Calendar: ASCO, ESMO, ASH & more
- Corrections: 32 published facts fixed, dated and sourced
- Data Coverage & Integrity
- PDUFA API: Free FDA Calendar & Biotech Catalyst API
- 2026 FDA Medical Device Calendar
- FDA approval decisions this week (Nov 9 to Nov 15, 2026): 3 decided, 3 due
- FDA Approval Letters: 103 FDA Decisions, Each Linked to the FDA's Own Record
- FDA Drug Approvals by Year & FDA Commissioner
- FDA Approvals by Month 2025-2026: Every New Application and New Use
- FDA Approvals April 2025: 17 New Applications, 33 New Uses
- FDA Approvals August 2025: 16 New Applications, 11 New Uses
- FDA Approvals December 2025: 17 New Applications, 25 New Uses
- FDA Approvals February 2025: 15 New Applications, 14 New Uses
- FDA Approvals January 2025: 7 New Applications, 16 New Uses
- FDA Approvals July 2025: 15 New Applications, 17 New Uses
- FDA Approvals June 2025: 15 New Applications, 25 New Uses
- FDA Approvals March 2025: 11 New Applications, 24 New Uses
- FDA Approvals May 2025: 8 New Applications, 22 New Uses
- FDA Approvals November 2025: 8 New Applications, 23 New Uses
- FDA Approvals October 2025: 20 New Applications, 30 New Uses
- FDA Approvals September 2025: 15 New Applications, 13 New Uses
- FDA Approvals April 2026: 4 New Applications, 22 New Uses
- FDA Approvals August 2026: 12 New Applications, 14 New Uses
- FDA Approvals February 2026: 13 New Applications, 22 New Uses
- FDA Approvals January 2026: 5 New Applications, 12 New Uses
- FDA Approvals July 2026: 16 New Applications, 19 New Uses
- FDA Approvals June 2026: 7 New Applications, 22 New Uses
- FDA Approvals March 2026: 10 New Applications, 20 New Uses
- FDA Approvals May 2026: 15 New Applications, 21 New Uses
- FDA Approvals November 2026: 0 New Applications, 1 New Uses
- FDA Approvals October 2026: 16 New Applications, 25 New Uses
- FDA Approvals September 2026: 16 New Applications, 16 New Uses
- FDA Decisions Today: PDUFA Approvals & CRLs, Updated Daily
- What the FDA Decides in November 2026: PDUFA Dates in Plain Language
- Biotech Glossary: PDUFA, CRL, Control Arm, Endpoints, Hazard Ratio
- Methodology: Facts, Not Approval Predictions
- Patent Cliff Tracker: 427 Drugs Losing Protection 2026-2031
- 2026 Patent Cliff: 19 Drugs Lose Patent Protection
- 2027 Patent Cliff: 64 Drugs Lose Patent Protection
- 2028 Patent Cliff: 80 Drugs Lose Patent Protection
- 2029 Patent Cliff: 87 Drugs Lose Patent Protection
- 2030 Patent Cliff: 75 Drugs Lose Patent Protection
- 2031 Patent Cliff: 102 Drugs Lose Patent Protection
- Blood Patent Cliff 2026-2031: 14 Drugs
- Cancer Patent Cliff 2026-2031: 40 Drugs
- Cardiovascular Patent Cliff 2026-2031: 29 Drugs
- Abbvie Patent Expirations 2026-2031: 14 Drugs
- Actelion Pharmaceuticals US Patent Expirations 2026-2031: 5 Drugs
- Astrazeneca AB Patent Expirations 2026-2031: 6 Drugs
- Azurity Pharmaceuticals Patent Expirations 2026-2031: 8 Drugs
- Bayer Healthcare Pharmaceuticals Patent Expirations 2026-2031: 10 Drugs
- Boehringer Ingelheim Pharmaceuticals Patent Expirations 2026-2031: 7 Drugs
- Cubist Pharmaceuticals Patent Expirations 2026-2031: 5 Drugs
- Gilead Sciences Patent Expirations 2026-2031: 5 Drugs
- Haleon US Holdings Patent Expirations 2026-2031: 5 Drugs
- Harrow EYE Patent Expirations 2026-2031: 5 Drugs
- Merck Sharp AND Dohme Patent Expirations 2026-2031: 18 Drugs
- Novartis Pharmaceuticals Patent Expirations 2026-2031: 11 Drugs
- PF Prism CV Patent Expirations 2026-2031: 5 Drugs
- Pfizer Patent Expirations 2026-2031: 5 Drugs
- Salix Pharmaceuticals Patent Expirations 2026-2031: 6 Drugs
- Takeda Pharmaceuticals USA Patent Expirations 2026-2031: 11 Drugs
- Teva Branded Pharmaceutical Products R AND D Patent Expirations 2026-2031: 5 Drugs
- Viiv Healthcare Patent Expirations 2026-2031: 8 Drugs
- Dermatology Patent Cliff 2026-2031: 27 Drugs
- Diabetes Patent Cliff 2026-2031: 22 Drugs
- FDA Exclusivity Expirations 2026-2031: 842 Brand-Drug Exclusivities
- Eye & ear Patent Cliff 2026-2031: 24 Drugs
- Genitourinary & hormones Patent Cliff 2026-2031: 32 Drugs
- Infectious disease Patent Cliff 2026-2031: 41 Drugs
- Metabolism & digestive Patent Cliff 2026-2031: 37 Drugs
- Musculoskeletal Patent Cliff 2026-2031: 16 Drugs
- Neurology & psychiatry Patent Cliff 2026-2031: 23 Drugs
- Pain Patent Cliff 2026-2031: 24 Drugs
- Psychiatry Patent Cliff 2026-2031: 16 Drugs
- Respiratory Patent Cliff 2026-2031: 34 Drugs
- Various Patent Cliff 2026-2031: 13 Drugs
- PDUFA Date Changes: Every FDA Goal Date We Have Seen Move
- API credit top-ups
- PDUFA Run-up by Year (2020-2026): 1,885 FDA Decisions With Real Price Data
- Biotech Catalyst Screener: filter PDUFAs, readouts, conferences & AdComms
- All pages on pdufa.bio: 1685 pages by section
- SLS (SELLAS Life Sciences) Tracker: REGAL Status & Every Catalyst
- Data Sources, Cadence & Coverage
- All Biotech Tickers We Track (A-Z): FDA Catalysts by Company
- Viking Therapeutics (VKTX): VK2735 Phase 3 Readout Dates
- Why pdufa.bio won't show a fake FDA approval
Calendar months · 16
Conditions · 10
Conferences · 39
- AACR Annual Meeting 2027: Apr 2-7, 2027, Orlando: biotech presenters
- AAD 2027: Mar 19-23, 2027, San Francisco: biotech presenters
- AAN 2027: May 1-5, 2027, Washington DC: biotech presenters
- AAO 2026: Oct 9-12, 2026, New Orleans: biotech presenters
- AASLD The Liver Meeting 2026: Nov 5-9, 2026, Denver: biotech presenters
- ACAAI 2026: Nov 12-16, 2026, Phoenix: biotech presenters
- ACC 2027: Apr 10-12, 2027, Houston: biotech presenters
- ACG 2026: Oct 9-14, 2026, Nashville: biotech presenters
- ACR Convergence 2026: Nov 6-11, 2026, Orlando: biotech presenters
- ADA 2027: Jun 18-21, 2027, Washington DC: biotech presenters
- American Epilepsy Society Annual Meeting 2026: Dec 4-8, 2026, Denver: biotech presenters
- AHA 2026: Nov 6-9, 2026, Chicago: biotech presenters
- ASBMR 2026: Oct 9-12, 2026, Boston: biotech presenters
- ASCO Annual Meeting 2027: Jun 4-8, 2027, Chicago: biotech presenters
- ASCO GI 2027: Jan 21-23, 2027, San Francisco: biotech presenters
- ASCO GU 2027: Feb 11-13, 2027, San Francisco: biotech presenters
- ASGCT 2027: May 3-7, 2027, Philadelphia: biotech presenters
- ASH 2026: Dec 12-15, 2026, New Orleans: biotech presenters
- ASN Kidney Week 2026: Oct 21-25, 2026, Denver: biotech presenters
- ATS 2027: May 14-19, 2027, New Orleans: biotech presenters
- Clinical Trials on Alzheimer's Disease 2026: Nov 16-19, 2026, Boston: biotech presenters
- Digestive Disease Week 2027: May 15-18, 2027, Washington DC: biotech presenters
- EASD 2026: Sep 28-Oct 2, 2026, Milan: biotech presenters
- EASL 2027: Jun 16-19, 2027, London: biotech presenters
- Joint ACTRIMS-ECTRIMS Meeting 2026: Oct 21-23, 2026, Toronto: biotech presenters
- EHA 2027: Jun 10-13, 2027, Barcelona: biotech presenters
- ENA 2026: Nov 18-20, 2026, Barcelona: biotech presenters
- ESC 2026: Aug 28-31, 2026, Munich: biotech presenters
- ESMO 2026: Oct 23-27, 2026, Madrid: biotech presenters
- ESMO Asia Congress 2026: Dec 4-6, 2026, Singapore: biotech presenters
- ESMO IO 2026: Dec 14-16, 2026, London: biotech presenters
- IDSA/SHEA/HIVMA IDWeek 2026: Oct 21-24, 2026, Washington DC: biotech presenters
- JPM 2027: Jan 11-14, 2027, San Francisco: biotech presenters
- ObesityWeek 2026: Nov 14-17, 2026, National Harbor: biotech presenters
- SABCS 2026: Dec 8-11, 2026, San Antonio: biotech presenters
- Society for Immunotherapy of Cancer 2026: Nov 4-8, 2026, Phoenix: biotech presenters
- SNO 2026: Nov 12-15, 2026, Philadelphia: biotech presenters
- IASLC World Conference on Lung Cancer 2026: Sep 12-15, 2026, Seoul: biotech presenters
- WORLD 2027: Jan 31-Feb 4, 2027, San Diego: biotech presenters
Complete response letters · 24
- FDA Complete Response Letter Database: 458 Released CRLs by Year
- FDA Complete Response Letters April 2025: 5 Released, 9 Tracked
- FDA Complete Response Letters August 2025: 6 Released, 4 Tracked
- FDA Complete Response Letters December 2025: 7 Released, 19 Tracked
- FDA Complete Response Letters February 2025: 0 Released, 3 Tracked
- FDA Complete Response Letters January 2025: 5 Released, 6 Tracked
- FDA Complete Response Letters July 2025: 7 Released, 10 Tracked
- FDA Complete Response Letters June 2025: 5 Released, 17 Tracked
- FDA Complete Response Letters March 2025: 7 Released, 5 Tracked
- FDA Complete Response Letters May 2025: 2 Released, 4 Tracked
- FDA Complete Response Letters November 2025: 4 Released, 10 Tracked
- FDA Complete Response Letters October 2025: 8 Released, 4 Tracked
- FDA Complete Response Letters September 2025: 3 Released, 4 Tracked
- FDA Complete Response Letters April 2026: 5 Released, 6 Tracked
- FDA Complete Response Letters August 2026: 1 Released, 0 Tracked
- FDA Complete Response Letters February 2026: 6 Released, 6 Tracked
- FDA Complete Response Letters January 2026: 3 Released, 2 Tracked
- FDA Complete Response Letters July 2026: 4 Released, 0 Tracked
- FDA Complete Response Letters June 2026: 9 Released, 4 Tracked
- FDA Complete Response Letters March 2026: 2 Released, 2 Tracked
- FDA Complete Response Letters May 2026: 2 Released, 0 Tracked
- FDA Complete Response Letters November 2026: 0 Released, 0 Tracked
- FDA Complete Response Letters October 2026: 0 Released, 0 Tracked
- FDA Complete Response Letters September 2026: 0 Released, 0 Tracked
Decision archives · 5
Drugs · 570
- FDA Drug Decision Index: Every Drug We Track
- 177Lu-TLX591: FDA Decision Dates & Catalyst History
- 18F-MFBG: FDA Decision Dates & Catalyst History
- 4D-150 IVT: FDA Decision Dates & Catalyst History
- 6-Thio-2'-Deoxyguanosine: FDA Decision Dates & Catalyst History
- A-101: FDA Decision Dates & Catalyst History
- AB-101: FDA Decision Dates & Catalyst History
- ABCL635: FDA Decision Dates & Catalyst History
- ABP 938: FDA Decision Dates & Catalyst History
- ACCG-2671: FDA Decision Dates & Catalyst History
- ACCG-2671 Phase: FDA Decision Dates & Catalyst History
- AD109 (Oxnimbi): FDA Decision Dates & Catalyst History
- ADCETRIS (brentuximab vedotin) FDA Approval: Approved Feb 12, 2025
- ADG106: FDA Decision Dates & Catalyst History
- Aficamten: FDA Decision Dates & Catalyst History
- Afrezza (Technosphere Insulin) FDA Approval: Approved May 29, 2026
- Aglatimagene Besadenovec: FDA Decision Dates & Catalyst History
- AGMB-129: FDA Decision Dates & Catalyst History
- AJOVY (fremanezumab-vfrm) FDA Approval: Approved Aug 6, 2025
- AKEEGA FDA Approval: Approved Dec 15, 2025
- AKY-1189: FDA Decision Dates & Catalyst History
- AL001: FDA Decision Dates & Catalyst History
- AL001 Phase: FDA Decision Dates & Catalyst History
- Albuterol sulfate FDA Approval: Approved Dec 2, 2025
- ALPHA-1 MP: FDA Decision Dates & Catalyst History
- ALT-803: FDA Decision Dates & Catalyst History
- AMBELVIST (gadoquatrane) FDA Approval: Approved Jun 15, 2026
- Ameluz (aminolevulinic acid hydrochloride) FDA Approval: Approved Sep 9, 2026
- Ampligen: FDA Decision Dates & Catalyst History
- AMVUTTRA (vutrisiran) FDA Approval: Approved Mar 20, 2025
- AN4035: FDA Decision Dates & Catalyst History
- Anaphylm (dibutepinephrine): FDA Decision Dates & Catalyst History
- ANB033: FDA Decision Dates & Catalyst History
- Andembry (garadacimab-gxii) FDA Approval: Approved Jun 16, 2025
- Anito-cel (anitocabtagene autoleucel): FDA Decision Dates & Catalyst History
- ANKTIVA (N-803) FDA Approval: Approved Oct 14, 2026
- Annamycin: FDA Decision Dates & Catalyst History
- AP01: FDA Decision Dates & Catalyst History
- APG777: FDA Decision Dates & Catalyst History
- Apitegromab FDA Approval: Approved Sep 11, 2026
- Apraglutide FDA Approval: Approved Apr 14, 2025
- AQVESME (mitapivat) FDA Approval: Approved Dec 23, 2025
- ARD-101: FDA Decision Dates & Catalyst History
- Arexvy FDA Approval: Approved Mar 13, 2026
- ARIKAYCE (amikacin liposome inhalation suspension) FDA Catalysts
- ARV-471: FDA Decision Dates & Catalyst History
- ASCENIV (RI-002) FDA Approval: Approved May 4, 2026
- Sunharbo (asundexian) FDA Approval: Approved Nov 9, 2026
- Atacicept: FDA Decision Dates & Catalyst History
- Atebrioz (zilurgisertib) FDA Approval: Approved Sep 25, 2026
- ATH-1105: FDA Decision Dates & Catalyst History
- Atumelnant: FDA Decision Dates & Catalyst History
- AUVELITY FDA Approval: Approved Apr 30, 2026
- Avance Nerve FDA Approval: Approved Dec 4, 2025
- Avexitide: FDA Decision Dates & Catalyst History
- AVLAYAH (Tividenofusp alfa) FDA Approval: Approved Mar 25, 2026
- AVMAPKI FAKZYNJA: FDA Decision Dates & Catalyst History
- AVT05 FDA Decision: Complete Response Letter Nov 2, 2025
- avutometinib: FDA Decision Dates & Catalyst History
- Awiqli (insulin icodec-abae) FDA Approval: Approved Mar 26, 2026
- AXS-12: FDA Decision Dates & Catalyst History
- AXS-14: FDA Decision Dates & Catalyst History
- AZURE-1: FDA Decision Dates & Catalyst History
- Balstilimab: FDA Decision Dates & Catalyst History
- Barzolvolimab: FDA Decision Dates & Catalyst History
- BAXFENDY (baxdrostat) FDA Approval: Approved May 18, 2026
- BBP-418 (ribitol): FDA Decision Dates & Catalyst History
- BDC-4182: FDA Decision Dates & Catalyst History
- BEAM-302: FDA Decision Dates & Catalyst History
- Bemnifosbuvir-Ruzasvir: FDA Decision Dates & Catalyst History
- Benlysta (belimumab) FDA Approval: Approved Jun 24, 2025
- Hibsago (bepirovirsen) FDA Approval: Approved Oct 20, 2026
- BEQALZI (Sonrotoclax) FDA Approval: Approved May 13, 2026
- bevacizumab: FDA Decision Dates & Catalyst History
- Bezuclastinib: FDA Decision Dates & Catalyst History
- BGB-11417: FDA Decision Dates & Catalyst History
- BGB-3111: FDA Decision Dates & Catalyst History
- BGE-102 (oral NLRP3 inhibitor): FDA Decision Dates & Catalyst History
- BHV-1300: FDA Decision Dates & Catalyst History
- Bictegravir FDA Approval: Approved Aug 27, 2026
- BIIB122: FDA Decision Dates & Catalyst History
- Bimatoprost ophthalmic FDA Approval: Approved Sep 23, 2025
- BIS-001: FDA Decision Dates & Catalyst History
- Bitopertin FDA Decision: Complete Response Letter Feb 15, 2026
- Blenrep FDA Approval: Approved Oct 23, 2025
- Blujepa (gepotidacin) FDA Approval: Approved Dec 11, 2025
- BMF-650: FDA Decision Dates & Catalyst History
- Botensilimab: FDA Decision Dates & Catalyst History
- BRAFTOVI (encorafenib) FDA Approval: Approved Feb 24, 2026
- Brekiya (dihydroergotamine mesylate) FDA Approval: Approved May 15, 2025
- Brepocitinib FDA Approval: Approved Aug 27, 2026
- BREZTRI AEROSPHERE FDA Approval: Approved Apr 28, 2026
- BRINSUPRI FDA Approval: Approved Aug 12, 2025
- Briquilimab: FDA Decision Dates & Catalyst History
- Bulevirtide: FDA Decision Dates & Catalyst History
- buntanetap/posiphen: FDA Decision Dates & Catalyst History
- Bysanti (milsaperidone) FDA Approval: Approved Feb 21, 2026
- CABOMETYX (cabozantinib) FDA Approval: Approved Mar 26, 2025
- Cabozantinib: FDA Decision Dates & Catalyst History
- CagriSema: FDA Decision Dates & Catalyst History
- CALQUENCE FDA Approval: Approved Feb 20, 2026
- Camizestrant FDA Approval: Approved Sep 4, 2026
- Camzyos (mavacamten) FDA Approval: Approved Sep 30, 2026
- Cannabidiol oral: FDA Decision Dates & Catalyst History
- CAPLYTA (lumateperone) FDA Approval: Approved Nov 6, 2025
- CAPVAXIVE FDA Approval: Approved Jun 18, 2026
- CARDAMYST (etripamil) FDA Approval: Approved Dec 15, 2025
- Casgevy (exagamglogene autotemcel) FDA Approval: Approved Jul 1, 2026
- Cemdisiran (C5 RNAi): FDA Decision Dates & Catalyst History
- Cemiplimab: FDA Decision Dates & Catalyst History
- Cemsidomide: FDA Decision Dates & Catalyst History
- Cenerimod: FDA Decision Dates & Catalyst History
- Centanafadine FDA Approval: Approved Jul 24, 2026
- CGT9486: FDA Decision Dates & Catalyst History
- CHS-1420: FDA Decision Dates & Catalyst History
- clemidsogene lanparvovec (RGX-121) FDA Decision: Complete Response Letter Feb 9, 2026
- cleminorexton: FDA Decision Dates & Catalyst History
- CLN-081: FDA Decision Dates & Catalyst History
- CM4620: FDA Decision Dates & Catalyst History
- CNTY-813: FDA Decision Dates & Catalyst History
- COMIRNATY LP.8.1 FDA Approval: Approved Aug 27, 2025
- COMP360 psilocybin: FDA Decision Dates & Catalyst History
- COSENTYX (secukinumab) FDA Approval: Approved Mar 13, 2026
- CPX-351: FDA Decision Dates & Catalyst History
- CRB-701: FDA Decision Dates & Catalyst History
- CTEXLI (chenodiol) FDA Approval: Approved Feb 24, 2025
- CTX-10726: FDA Decision Dates & Catalyst History
- CTx-1301 (fixed dose, pediatric study) FDA Catalysts
- Cytisinicline FDA Decision: Complete Response Letter Jun 22, 2026
- D-PLEX100: FDA Decision Dates & Catalyst History
- DA-1726: FDA Decision Dates & Catalyst History
- Daraxonrasib (RMC-6236) FDA Approval: Approved Aug 26, 2026
- Darovasertib: FDA Decision Dates & Catalyst History
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) FDA Approval: Approved Jan 27, 2026
- Datopotamab Deruxtecan (Dato-DXd) FDA Approval: Approved May 22, 2026
- DATROWAY (datopotamab deruxtecan-dlnk) FDA Approval: Approved Jun 23, 2025
- Dawnzera (donidalorsen) FDA Approval: Approved Aug 21, 2025
- DAYBUE STIX (trofinetide) FDA Approval: Approved Dec 12, 2025
- Decartes-08: FDA Decision Dates & Catalyst History
- Decoy20: FDA Decision Dates & Catalyst History
- Degevma (denosumab-adet) FDA Approval: Approved Sep 25, 2026
- DehydraTECH FDA Approval: Approved Jan 15, 2025
- Deramiocel (CAP-1002): FDA Decision Dates & Catalyst History
- deucrictibant: FDA Decision Dates & Catalyst History
- Deucrictibant IR: FDA Decision Dates & Catalyst History
- Dextromethorphan-Bupropion: FDA Decision Dates & Catalyst History
- DISC-3405: FDA Decision Dates & Catalyst History
- Donidalorsen: FDA Decision Dates & Catalyst History
- Dordaviprone FDA Approval: Approved Aug 6, 2025
- DT120: FDA Decision Dates & Catalyst History
- DTX401 (pariglasgene brecaparvovec) FDA Approval: Approved Aug 19, 2026
- Dupixent (dupilumab) FDA Approval: Approved Apr 22, 2026
- DURAVYU COMO: FDA Decision Dates & Catalyst History
- EBGLYSS (lebrikizumab-lbkz) FDA Approval: Approved Jun 9, 2026
- EBVALLO FDA Decision: Complete Response Letter Jan 12, 2026
- EDP-978: FDA Decision Dates & Catalyst History
- eftilagimod alfa: FDA Decision Dates & Catalyst History
- EKTERLY (sebetralstat) FDA Approval: Approved Jul 7, 2025
- elebsiran: FDA Decision Dates & Catalyst History
- ELI-002 7P: FDA Decision Dates & Catalyst History
- Elranatamab: FDA Decision Dates & Catalyst History
- ELVN-002: FDA Decision Dates & Catalyst History
- EMBLAVEO (aztreonam and avibactam) FDA Approval: Approved Feb 7, 2025
- EMPAVELI (pegcetacoplan) FDA Approval: Approved Jul 28, 2025
- EMRELIS FDA Approval: Approved May 14, 2025
- Encaleret: FDA Decision Dates & Catalyst History
- ENFLONSIA (clesrovimab): FDA Decision Dates & Catalyst History
- Enhertu (trastuzumab deruxtecan) FDA Approval: Approved May 15, 2026
- Ensifentrine: FDA Decision Dates & Catalyst History
- Enspryng (satralizumab-mwge): FDA Decision Dates & Catalyst History
- Envudeucitinib LUMUS: FDA Decision Dates & Catalyst History
- Epioxa FDA Approval: Approved Oct 20, 2025
- EPKINLY (epcoritamab-bysp) FDA Approval: Approved Nov 18, 2025
- Etcamah (camizestrant) FDA Approval: Approved Sep 4, 2026
- Eteplirsen: FDA Decision Dates & Catalyst History
- Everolimus FDA Approval: Approved Jan 23, 2025
- EVO756: FDA Decision Dates & Catalyst History
- EVRYSDI (risdiplam) FDA Approval: Approved Feb 12, 2025
- Exdensur (depemokimab) FDA Approval: Approved Dec 16, 2025
- EYLEA HD (aflibercept) FDA Approval: Approved Apr 2, 2026
- EYP-1901: FDA Decision Dates & Catalyst History
- Fabhalta (iptacopan) FDA Approval: Approved Mar 20, 2025
- fasedienol: FDA Decision Dates & Catalyst History
- FAYUVI FDA Approval: Approved Sep 17, 2026
- FCX-007: FDA Decision Dates & Catalyst History
- Felzartamab: FDA Decision Dates & Catalyst History
- FG-3246: FDA Decision Dates & Catalyst History
- FILSPARI (sparsentan) FDA Approval: Approved Apr 13, 2026
- Foundayo (orforglipron) FDA Approval: Approved Apr 1, 2026
- FUROSCIX ReadyFlow FDA Approval: Approved Jul 23, 2026
- galinpepimut-S: FDA Decision Dates & Catalyst History
- GAMMAGARD LIQUID FDA Approval: Approved Jun 30, 2025
- Garadacimab FDA Approval: Approved Jun 17, 2025
- Garetosmab FDA Approval: Approved Aug 19, 2026
- Gazyva (obinutuzumab): FDA Decision Dates & Catalyst History
- Gedatolisib FDA Approval: Approved Jul 14, 2026
- Giredestrant (+ everolimus): FDA Decision Dates & Catalyst History
- GOMEKLI (mirdametinib) FDA Approval: Approved Feb 11, 2025
- Gozellix FDA Approval: Approved Mar 21, 2025
- GTX-102: FDA Decision Dates & Catalyst History
- GTX-104 FDA Decision: Complete Response Letter Apr 23, 2026
- Gvoke VialDx FDA Approval: Approved Mar 17, 2025
- GX-03: FDA Decision Dates & Catalyst History
- Halneuron: FDA Decision Dates & Catalyst History
- Hepcludex (Bulevirtide) FDA Approval: Approved May 26, 2026
- HLP003: FDA Decision Dates & Catalyst History
- Human Acellular: FDA Decision Dates & Catalyst History
- HWK-007: FDA Decision Dates & Catalyst History
- HYMPAVZI (marstacimab) FDA Approval: Approved Jun 8, 2026
- Hypericin: FDA Decision Dates & Catalyst History
- HYRNUO (sevabertinib) FDA Approval: Approved Sep 9, 2026
- iberdomide FDA Approval: Approved Aug 13, 2026
- IBRANCE (palbociclib) FDA Approval: Approved Jun 24, 2026
- IBTROZI (taletrectinib) FDA Approval: Approved Sep 16, 2026
- ICOTYDE (icotrokinra) FDA Approval: Approved Mar 18, 2026
- IDose TR FDA Approval: Approved Jan 28, 2026
- IDVYNSO (doravirine/islatravir): FDA Decision Dates & Catalyst History
- Ifezuntirgene inilparvovec (AMT-130): FDA Decision Dates & Catalyst History
- Ifinatamab deruxtecan (I-DXd): FDA Decision Dates & Catalyst History
- IGALMI (dexmedetomidine sublingual film): FDA Decision Dates & Catalyst History
- IHL-42X Low: FDA Decision Dates & Catalyst History
- ILUVIEN FDA Approval: Approved Mar 14, 2025
- IM1305: FDA Decision Dates & Catalyst History
- IMAAVY FDA Approval: Approved Apr 30, 2025
- IMCIVREE (setmelanotide) FDA Approval: Approved Mar 20, 2026
- IMFINZI (durvalumab) FDA Approval: Approved May 28, 2026
- Imsidolimab: FDA Decision Dates & Catalyst History
- IMU-838 tablets: FDA Decision Dates & Catalyst History
- IMVT-1402: FDA Decision Dates & Catalyst History
- INBRX-106: FDA Decision Dates & Catalyst History
- INLEXZO (gemcitabine intravesical system) FDA Approval: Approved Sep 9, 2025
- Inluriyo (imlunestrant) FDA Approval: Approved Sep 18, 2026
- INT230-6: FDA Decision Dates & Catalyst History
- Iohexol injection FDA Approval: Approved Nov 13, 2025
- ION582: FDA Decision Dates & Catalyst History
- Ipratropium Bromide FDA Approval: Approved Feb 24, 2026
- Iptacopan: FDA Decision Dates & Catalyst History
- Iron Sucrose FDA Approval: Approved Aug 11, 2025
- ISEMBYLD (apitegromab-mstn) FDA Approval: Approved Sep 11, 2026
- Isosorbide Mononitrate FDA Approval: Approved Apr 8, 2026
- Itvisma (onasemnogene abeparvovec-brve) FDA Approval: Approved Nov 24, 2025
- IVA337: FDA Decision Dates & Catalyst History
- Ivonescimab: FDA Decision Dates & Catalyst History
- IZERVAY (avacincaptad pegol intravitreal solution) FDA Approval: Approved Feb 13, 2025
- J.P. Morgan: FDA Decision Dates & Catalyst History
- Jakafi XR (ruxolitinib) FDA Approval: Approved May 1, 2026
- Jaypirca (pirtobrutinib) FDA Approval: Approved Oct 2, 2026
- Jemperli (dostarlimab-gxly) FDA Approval: Approved Oct 19, 2026
- Joenja (leniolisib): FDA Decision Dates & Catalyst History
- JUV FDA Approval: Approved Jun 16, 2026
- KERENDIA (finerenone) FDA Approval: Approved Sep 16, 2026
- KETARX (ketamine) FDA Approval: Approved Aug 11, 2025
- KEYTRUDA (pembrolizumab) FDA Approval: Approved Jul 10, 2026
- KEYTRUDA QLEX FDA Approval: Approved Sep 19, 2025
- KHINDIVI FDA Approval: Approved May 29, 2025
- KOMZIFTI (ziftomenib) FDA Approval: Approved Nov 13, 2025
- Koselugo (selumetinib) FDA Approval: Approved Nov 20, 2025
- KRESLADI (marnetegragene autotemcel) FDA Approval: Approved Mar 27, 2026
- KRRO-121 ANCHOR: FDA Decision Dates & Catalyst History
- KSI-501: FDA Decision Dates & Catalyst History
- KT-621: FDA Decision Dates & Catalyst History
- Kygevvi (doxecitine and doxribtimine) FDA Approval: Approved Nov 3, 2025
- KYV-101: FDA Decision Dates & Catalyst History
- KYV-101 KYSA-1: FDA Decision Dates & Catalyst History
- KYV101: FDA Decision Dates & Catalyst History
- LAM-001: FDA Decision Dates & Catalyst History
- lanifibranor NATiV3: FDA Decision Dates & Catalyst History
- LCAR-B38M CAR-T: FDA Decision Dates & Catalyst History
- Leniolisib: FDA Decision Dates & Catalyst History
- LEQEMBI (lecanemab-irmb) FDA Approval: Approved Jan 26, 2025
- LEQEMBI IQLIK (lecanemab-irmb) FDA Approval: Approved Jul 13, 2026
- LIBERVANT (diazepam): FDA Decision Dates & Catalyst History
- Libtayo (cemiplimab-rwlc) FDA Approval: Approved Oct 8, 2025
- Lifileucel: FDA Decision Dates & Catalyst History
- Linerixibat FDA Approval: Approved Mar 19, 2026
- LINZESS (Iinaclotide) FDA Approval: Approved May 27, 2026
- Lipfendra (enlicitide decanoate) FDA Approval: Approved Jul 15, 2026
- Litifilimab: FDA Decision Dates & Catalyst History
- LIVMARLI (maralixibat) FDA Approval: Approved Apr 14, 2025
- LNTH-2501 (Gallium-68 edotreotide) FDA Decision: Complete Response Letter Jun 26, 2026
- Loncastuximab Tesirine: FDA Decision Dates & Catalyst History
- Lonvoguran ziclumeran (lonvo-z): FDA Decision Dates & Catalyst History
- lorundrostat: FDA Decision Dates & Catalyst History
- Losartan: FDA Decision Dates & Catalyst History
- LUMAKRAS FDA Approval: Approved Jan 17, 2025
- Lunsumio VELO (mosunetuzumab-axgb): FDA Decision Dates & Catalyst History
- Lurbinectedin FDA Approval: Approved Oct 2, 2025
- LX1001: FDA Decision Dates & Catalyst History
- Lynkuet (elinzanetant) FDA Approval: Approved Oct 24, 2025
- Lynozyfic (linvoseltamab-gcpt) FDA Approval: Approved Jul 2, 2025
- LYTENAVA (bevacizumab-vikg) FDA Decision: Complete Response Letter Apr 7, 2026
- MAR002 Phase: FDA Decision Dates & Catalyst History
- MAVYRET FDA Approval: Approved Jun 11, 2025
- MBX 2109: FDA Decision Dates & Catalyst History
- Mecbotamab Vedotin FDA Approval: Approved Nov 7, 2025
- Mezigdomide: FDA Decision Dates & Catalyst History
- MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) FDA Approval: Approved Aug 5, 2026
- Mim8 (denecimig): FDA Decision Dates & Catalyst History
- Mirikizumab: FDA Decision Dates & Catalyst History
- Mitapivat: FDA Decision Dates & Catalyst History
- MK-3475: FDA Decision Dates & Catalyst History
- MK-6240 FDA Approval: Approved Aug 13, 2026
- MK-7240: FDA Decision Dates & Catalyst History
- MK-8527: FDA Decision Dates & Catalyst History
- ML-007C-MA Phase: FDA Decision Dates & Catalyst History
- MN-166: FDA Decision Dates & Catalyst History
- MNKD-201: FDA Decision Dates & Catalyst History
- MOLBREEVI (molgramostim inhalation): FDA Decision Dates & Catalyst History
- Molgramostim: FDA Decision Dates & Catalyst History
- Monalizumab: FDA Decision Dates & Catalyst History
- MONJUVI (tafasitamab) FDA Approval: Approved Jun 18, 2025
- MR-100A-01 FDA Approval: Approved Jul 28, 2026
- MR-107A-02 (fast-acting meloxicam): FDA Decision Dates & Catalyst History
- MR-141 (phentolamine ophthalmic solution 0.75%): FDA Decision Dates & Catalyst History
- MYQORZO FDA Approval: Approved Dec 19, 2025
- Nalbuphine ER: FDA Decision Dates & Catalyst History
- Naporafenib: FDA Decision Dates & Catalyst History
- NBTXR3: FDA Decision Dates & Catalyst History
- NE3107: FDA Decision Dates & Catalyst History
- neffy (epinephrine nasal spray) FDA Approval: Approved Mar 27, 2026
- Neffy 1 FDA Approval: Approved Mar 5, 2025
- Neladalkib (NVL-655): FDA Decision Dates & Catalyst History
- neratinib: FDA Decision Dates & Catalyst History
- NEREUS (tradipitant) FDA Approval: Approved Dec 30, 2025
- nimacimab: FDA Decision Dates & Catalyst History
- Niraparib: FDA Decision Dates & Catalyst History
- Nivolumab: FDA Decision Dates & Catalyst History
- NMRA-511: FDA Decision Dates & Catalyst History
- NOV-002: FDA Decision Dates & Catalyst History
- Nucala (mepolizumab) FDA Approval: Approved May 22, 2025
- NUVAXOVID FDA Approval: Approved Aug 27, 2025
- NUZOLVENCE (zoliflodacin) FDA Approval: Approved Dec 15, 2025
- NXC-201: FDA Decision Dates & Catalyst History
- Obexelimab: FDA Decision Dates & Catalyst History
- OCU400: FDA Decision Dates & Catalyst History
- Odronextamab: FDA Decision Dates & Catalyst History
- olevaprubart (IMG-007): FDA Decision Dates & Catalyst History
- Olezarsen: FDA Decision Dates & Catalyst History
- Olumiant (baricitinib) FDA Approval: Approved Sep 25, 2026
- Omvoh (mirikizumab-mrkz) FDA Approval: Approved Oct 27, 2025
- ONAPGO (apomorphine hydrochloride) FDA Approval: Approved Feb 4, 2025
- Onswik (insulin efsitora alfa-gobe) FDA Approval: Approved Sep 23, 2026
- Onvansertib: FDA Decision Dates & Catalyst History
- Opdivo (nivolumab) FDA Approval: Approved Mar 20, 2026
- OPGx-BEST1 BIRD-1: FDA Decision Dates & Catalyst History
- Optune Pax (Tumor Treating Fields) FDA Approval: Approved Feb 11, 2026
- OPUS-1: FDA Decision Dates & Catalyst History
- Opzelura FDA Approval: Approved Sep 19, 2025
- Oral infigratinib: FDA Decision Dates & Catalyst History
- ORLADEYO (berotralstat) FDA Approval: Approved Dec 12, 2025
- Otarmeni (lunsotogene parvec-cwha) FDA Approval: Approved Apr 23, 2026
- OTC NARCAN FDA Approval: Approved Feb 12, 2026
- Oveporexton (TAK-861-2001) FDA Approval: Approved Aug 5, 2026
- Oxylanthanum Carbonate FDA Decision: Complete Response Letter Jun 30, 2026
- Ozekibart (INBRX-109): FDA Decision Dates & Catalyst History
- Oziltus (denosumab-mobz) FDA Approval: Approved Dec 22, 2025
- PADCEV (enfortumab vedotin) FDA Approval: Approved Nov 21, 2025
- Palazestrant: FDA Decision Dates & Catalyst History
- Palbociclib FDA Approval: Approved Jun 24, 2026
- PALSONIFY (paltusotine) FDA Approval: Approved Sep 25, 2025
- PALYNZIQ (pegvaliase-pqpz) FDA Approval: Approved Feb 27, 2026
- PAPZIMEOS (zopapogene imadenovec-drba) FDA Approval: Approved Aug 15, 2025
- Paxalisib FDA Approval: Approved Jan 2, 2025
- paxalisib Stage: FDA Decision Dates & Catalyst History
- Pembrolizumab: FDA Decision Dates & Catalyst History
- Penpulimab FDA Approval: Approved Apr 23, 2025
- Phentolamine ophthalmic: FDA Decision Dates & Catalyst History
- PI-2620: FDA Decision Dates & Catalyst History
- Pimjetmi (pimicotinib) FDA Approval: Approved Nov 10, 2026
- Pitolisant GR (gastro-resistant formulation): FDA Decision Dates & Catalyst History
- Pixclara (floretyrosine F 18; TLX101-Px) FDA Approval: Approved Sep 11, 2026
- Plinabulin: FDA Decision Dates & Catalyst History
- Pluvicto FDA Approval: Approved Jul 31, 2026
- PMN310: FDA Decision Dates & Catalyst History
- POHERDY (pertuzumab-dpzb) FDA Approval: Approved Nov 17, 2025
- PONLIMSI (denosumab-adet) FDA Approval: Approved Mar 30, 2026
- Povetacicept (ALPN-303): FDA Decision Dates & Catalyst History
- Povorcitinib: FDA Decision Dates & Catalyst History
- Prucalopride Tablets FDA Approval: Approved Jan 2, 2025
- PTC923: FDA Decision Dates & Catalyst History
- PYLARIFY TruVu (piflufolastat F 18) FDA Approval: Approved Mar 6, 2026
- Qfitlia (fitusiran) FDA Approval: Approved Mar 28, 2025
- QTORIN rapamycin: FDA Decision Dates & Catalyst History
- RAP-219: FDA Decision Dates & Catalyst History
- Rasonque (daraxonrasib) FDA Approval: Approved Aug 26, 2026
- Reblozyl (luspatercept): FDA Decision Dates & Catalyst History
- Recombinant Single-Chain: FDA Decision Dates & Catalyst History
- REDEMPLO (plozasiran) FDA Approval: Approved Nov 18, 2025
- REGEN-006: FDA Decision Dates & Catalyst History
- Relacorilant: FDA Decision Dates & Catalyst History
- Relutrigine (PRAX-562): FDA Decision Dates & Catalyst History
- Remibrutinib: FDA Decision Dates & Catalyst History
- REOLYSIN: FDA Decision Dates & Catalyst History
- Repatha (evolocumab) FDA Approval: Approved Oct 9, 2026
- Reproxalap (ADX-102) FDA Decision: Complete Response Letter Mar 17, 2026
- Resmetirom: FDA Decision Dates & Catalyst History
- Revuforj (revumenib) FDA Approval: Approved Oct 24, 2025
- Rexlemestrocel-L: FDA Decision Dates & Catalyst History
- RGX FDA Decision: Complete Response Letter Feb 8, 2026
- RGX-314: FDA Decision Dates & Catalyst History
- Rhapsido (remibrutinib) FDA Approval: Approved Oct 6, 2026
- rigosertib: FDA Decision Dates & Catalyst History
- Rilzabrutinib: FDA Decision Dates & Catalyst History
- RINVOQ (upadacitinib) FDA Approval: Approved Oct 13, 2025
- Risperidone Extended FDA Approval: Approved Sep 4, 2025
- Romidepsin injection FDA Approval: Approved Jun 4, 2026
- Romvimza (vimseltinib) FDA Approval: Approved Feb 14, 2025
- RP1 (vusolimogene oderparepvec) FDA Decision: Complete Response Letter Apr 10, 2026
- Rusfertide FDA Approval: Approved Aug 28, 2026
- Ruxolitinib: FDA Decision Dates & Catalyst History
- Rybelsus (oral semaglutide) FDA Approval: Approved Oct 15, 2025
- RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) FDA Catalysts
- RYZUMVI (phentolamine) FDA Approval: Approved Oct 16, 2026
- S-303 Treated: FDA Decision Dates & Catalyst History
- S095035: FDA Decision Dates & Catalyst History
- sabirnetug: FDA Decision Dates & Catalyst History
- Sacituzumab Govitecan: FDA Decision Dates & Catalyst History
- Sacituzumab tirumotecan (sac-TMT): FDA Decision Dates & Catalyst History
- safusidenib: FDA Decision Dates & Catalyst History
- SAPHNELO (anifrolumab-fnia) FDA Approval: Approved Apr 27, 2026
- SCY-247: FDA Decision Dates & Catalyst History
- SD-101: FDA Decision Dates & Catalyst History
- SELARSDI (ustekinumab-aekn) FDA Approval: Approved May 5, 2025
- Selinexor: FDA Decision Dates & Catalyst History
- Semaglutide: FDA Decision Dates & Catalyst History
- SEPHIENCE FDA Approval: Approved Jul 28, 2025
- Seralutinib: FDA Decision Dates & Catalyst History
- Setmelanotide FDA Approval: Approved Mar 20, 2026
- Setrusumab: FDA Decision Dates & Catalyst History
- SGT-003: FDA Decision Dates & Catalyst History
- SGT-610: FDA Decision Dates & Catalyst History
- Shingrix (prefilled syringe) FDA Approval: Approved Jul 17, 2025
- SION-719: FDA Decision Dates & Catalyst History
- SKYRIZI (risankizumab-rzaa) FDA Approval: Approved Jun 26, 2026
- SKYTROFA FDA Approval: Approved Jul 28, 2025
- SL-846: FDA Decision Dates & Catalyst History
- SLN124: FDA Decision Dates & Catalyst History
- SLS009 (tambiciclib): FDA Decision Dates & Catalyst History
- SNDX-62122: FDA Decision Dates & Catalyst History
- SNS-101: FDA Decision Dates & Catalyst History
- Sodium oxybate FDA Approval: Approved Sep 11, 2025
- Sogroya (somapacitan) FDA Approval: Approved Mar 3, 2026
- Solnerstotug FDA Decision: Complete Response Letter Oct 17, 2025
- Sonelokimab: FDA Decision Dates & Catalyst History
- Sotagliflozin: FDA Decision Dates & Catalyst History
- Sotyktu (deucravacitinib) FDA Approval: Approved Mar 6, 2026
- SPINRAZA (Nusinersen) FDA Approval: Approved Mar 30, 2026
- SPN-812: FDA Decision Dates & Catalyst History
- SPRAVATO (esketamine) FDA Approval: Approved Jan 21, 2025
- SPY001: FDA Decision Dates & Catalyst History
- Sublingual film: FDA Decision Dates & Catalyst History
- SUBLOCADE (buprenorphine extended-release) FDA Approval: Approved Feb 24, 2025
- SURF303 Phase: FDA Decision Dates & Catalyst History
- Susvimo (ranibizumab injection) FDA Approval: Approved May 22, 2025
- Suzetrigine FDA Approval: Approved Jan 30, 2025
- SYMBRAVO (meloxicam and rizatriptan) FDA Approval: Approved Jan 30, 2025
- Taldefgrobep Alfa: FDA Decision Dates & Catalyst History
- Tanruprubart: FDA Decision Dates & Catalyst History
- Tarlatamab FDA Approval: Approved Nov 19, 2025
- JUVMO (tavapadon) FDA Approval: Approved Sep 25, 2026
- Tavocept: FDA Decision Dates & Catalyst History
- Tebipenem HBr FDA Approval: Approved Jun 17, 2026
- Tecentriq (atezolizumab) FDA Approval: Approved Oct 8, 2026
- Tecovirimat Oral: FDA Decision Dates & Catalyst History
- TECVAYLI (teclistamab-cqyv) FDA Approval: Approved Mar 5, 2026
- Temozolomide: FDA Decision Dates & Catalyst History
- Tenapanor: FDA Decision Dates & Catalyst History
- Teriparatide injection FDA Approval: Approved Dec 15, 2025
- Tezepelumab FDA Approval: Approved Oct 17, 2025
- TEZSPIRE (tezepelumab-ekko) FDA Approval: Approved Oct 17, 2025
- TH103: FDA Decision Dates & Catalyst History
- Tibulizumab: FDA Decision Dates & Catalyst History
- Tinlarebant: FDA Decision Dates & Catalyst History
- Mounjaro (tirzepatide): FDA Decision Dates & Catalyst History
- Tislelizumab: FDA Decision Dates & Catalyst History
- TLX101 FDA Decision: Complete Response Letter Apr 28, 2025
- TNKase (tenecteplase) FDA Approval: Approved Mar 3, 2025
- TNX-103 (oral levosimendan): FDA Decision Dates & Catalyst History
- Tobevibart: FDA Decision Dates & Catalyst History
- Tolebrutinib FDA Decision: Complete Response Letter Dec 28, 2025
- Tonmya FDA Approval: Approved Aug 15, 2025
- Topical Roflumilast: FDA Decision Dates & Catalyst History
- TP-03: FDA Decision Dates & Catalyst History
- Tradipitant: FDA Decision Dates & Catalyst History
- TransCon CNP (navepegritide): FDA Decision Dates & Catalyst History
- TRB-061 (TNFR2 agonist): FDA Decision Dates & Catalyst History
- TREMFYA (guselkumab) FDA Approval: Approved May 29, 2026
- trenibotulinumtoxinE (TrenibotE) FDA Decision: Complete Response Letter Apr 23, 2026
- Treprostinil Palmitil: FDA Decision Dates & Catalyst History
- Triheptanoin: FDA Decision Dates & Catalyst History
- Trodelvy (sacituzumab govitecan-hziy) FDA Approval: Approved Jun 24, 2026
- Truqap FDA Approval: Approved Jun 12, 2026
- TRYPTYR (acoltremon ophthalmic solution) FDA Approval: Approved May 28, 2025
- TSHA-101: FDA Decision Dates & Catalyst History
- TTFields therapy (Optune): FDA Decision Dates & Catalyst History
- TTX FDA Approval: Approved Mar 13, 2025
- TUDRIQEV (vusolimogene oderparepvec-wtpg) FDA Approval: Approved Aug 6, 2026
- Tukysa (tucatinib) FDA Approval: Approved Oct 7, 2026
- TX2100: FDA Decision Dates & Catalyst History
- UCART22: FDA Decision Dates & Catalyst History
- UGN-103 (mitomycin): FDA Decision Dates & Catalyst History
- ulixacaltamide: FDA Decision Dates & Catalyst History
- Ultomiris (ravulizumab) FDA Approval: Approved Oct 21, 2026
- Upadacitinib FDA Approval: Approved Oct 13, 2025
- UPLIZNA FDA Approval: Approved Dec 11, 2025
- Uproleselan: FDA Decision Dates & Catalyst History
- UX111 FDA Decision: Complete Response Letter Jul 11, 2025
- UZEDY FDA Approval: Approved Oct 10, 2025
- Vadadustat: FDA Decision Dates & Catalyst History
- Vanrafia (atrasentan) FDA Approval: Approved Apr 3, 2025
- Varegacestat: FDA Decision Dates & Catalyst History
- VAX-31 OPUS-2: FDA Decision Dates & Catalyst History
- VDPHL01: FDA Decision Dates & Catalyst History
- Veligrotug (VRDN-001) FDA Approval: Approved Jun 26, 2026
- Venglustat: FDA Decision Dates & Catalyst History
- VEPPANU (vepdegestrant) FDA Approval: Approved May 1, 2026
- Verekitug: FDA Decision Dates & Catalyst History
- VGX-3100: FDA Decision Dates & Catalyst History
- VIZZ (aceclidine ophthalmic solution) FDA Approval: Approved Jul 31, 2025
- VK2735: FDA Decision Dates & Catalyst History
- VLS-01: FDA Decision Dates & Catalyst History
- VOCERYQ (INO-3107) FDA Approval: Approved Oct 30, 2026
- Vonoprazan: FDA Decision Dates & Catalyst History
- VOXZOGO (vosoritide): FDA Decision Dates & Catalyst History
- VQW-765: FDA Decision Dates & Catalyst History
- VSJ-110: FDA Decision Dates & Catalyst History
- VXA-COV2-3.3: FDA Decision Dates & Catalyst History
- VY7523: FDA Decision Dates & Catalyst History
- VYD2311: FDA Decision Dates & Catalyst History
- VYKAT XR (diazoxide choline) FDA Approval: Approved Mar 26, 2025
- VYVGART FDA Approval: Approved May 8, 2026
- VYVGART Hytrulo (efgartigimod) FDA Approval: Approved Apr 10, 2025
- WAKIX (pitolisant) FDA Approval: Approved Feb 17, 2026
- Wayrilz (rilzabrutinib) FDA Approval: Approved Aug 29, 2025
- Wegovy (semaglutide) FDA Approval: Approved Aug 15, 2025
- Wegovy HD FDA Approval: Approved Mar 19, 2026
- WELIREG (belzutifan) FDA Approval: Approved Sep 24, 2026
- Weltruza (olanzapine) FDA Approval: Approved Oct 8, 2026
- WINREVAIR (sotatercept-csrk) FDA Approval: Approved Sep 21, 2026
- WTX-330: FDA Decision Dates & Catalyst History
- WVE FDA Approval: Approved Mar 26, 2025
- WVE-210201: FDA Decision Dates & Catalyst History
- XEN1701: FDA Decision Dates & Catalyst History
- XMAB20717: FDA Decision Dates & Catalyst History
- XRx FDA Approval: Approved Apr 30, 2025
- YARTEMLEA FDA Approval: Approved Dec 24, 2025
- Yescarta (axicabtagene ciloleucel) FDA Approval: Approved Feb 6, 2026
- Yeztugo (lenacapavir): FDA Decision Dates & Catalyst History
- Yutiq: FDA Decision Dates & Catalyst History
- YUTREPIA (treprostinil) FDA Approval: Approved May 23, 2025
- YUVIWEL (navepegritide) FDA Approval: Approved Feb 27, 2026
- z-basivarsen ACHIEVE: FDA Decision Dates & Catalyst History
- Z-Endoxifen: FDA Decision Dates & Catalyst History
- Z-rostudirsen: FDA Decision Dates & Catalyst History
- Zanidatamab FDA Approval: Approved Aug 25, 2026
- Zanubrutinib: FDA Decision Dates & Catalyst History
- Zanzalintinib: FDA Decision Dates & Catalyst History
- ZB021: FDA Decision Dates & Catalyst History
- Zegfrovy (sunvozertinib) FDA Approval: Approved Jul 2, 2025
- Zepzelca (lurbinectedin) FDA Approval: Approved Oct 2, 2025
- ZEVASKYN (prademagene zamikeracel) FDA Approval: Approved Apr 29, 2025
- Zidesamtinib (NVL-520) FDA Approval: Approved Jul 22, 2026
- Ziihera (zanidatamab-hrii) FDA Approval: Approved Aug 25, 2026
- Zilganersen FDA Approval: Approved Sep 3, 2026
- Zimberelimab: FDA Decision Dates & Catalyst History
- Zipalertinib (CLN-081): FDA Decision Dates & Catalyst History
- ZORYVE (roflumilast): FDA Decision Dates & Catalyst History
- ZUSDURI FDA Approval: Approved Jun 12, 2025
- ZYCUBO (copper histidinate) FDA Approval: Approved Jan 13, 2026
- Zynyz (retifanlimab-dlwr) FDA Decision: Complete Response Letter Apr 8, 2026
FDA decisions · 376
- EMBLAVEO Approved Feb 7, 2025 | ABBV FDA Decision
- Vanrafia Approved Apr 2, 2025 | ABBV FDA Decision
- Upadacitinib Approved Apr 29, 2025 | ABBV FDA Decision
- EMRELIS Approved May 14, 2025 | ABBV FDA Decision
- MAVYRET Approved Jun 11, 2025 | ABBV FDA Decision
- RINVOQ Approved Oct 13, 2025 | ABBV FDA Decision
- EPKINLY Approved Nov 18, 2025 | ABBV FDA Decision
- ABBV FDA Decision: Approved Feb 20, 2026
- trenibotulinumtoxinE (TrenibotE) CRL Apr 23, 2026 | ABBV FDA Decision
- LINZESS (Iinaclotide) Approved May 27, 2026 | ABBV FDA Decision
- JUVÉDERM - (SKINVIVE) (injectable HA) Approved Jun 16, 2026 | ABBV FDA Decision
- SKYRIZI (risankizumab-rzaa) Approved Jun 26, 2026 | ABBV FDA Decision
- JUVMO (tavapadon) Approved Sep 25, 2026 | ABBV FDA Decision
- ZEVASKYN Approved Apr 29, 2025 | ABEO FDA Decision
- DAYBUE STIX Approved Dec 12, 2025 | ACAD FDA Decision
- Cytisinicline CRL Jun 20, 2026 | ACHV FDA Decision
- ASCENIV (RI-002) Approved May 4, 2026 | ADMA FDA Decision
- Kygevvi Approved Nov 3, 2025 | AGIO FDA Decision
- AQVESME Approved Dec 23, 2025 | AGIO FDA Decision
- TRYPTYR Approved May 28, 2025 | ALC FDA Decision
- ALDX FDA Decision: CRL Apr 3, 2025
- Reproxalap (ADX-102) CRL Mar 17, 2026 | ALDX FDA Decision
- ALLO FDA Decision: CRL Feb 14, 2025
- AMVUTTRA Approved Mar 20, 2025 | ALNY FDA Decision
- Qfitlia Approved Mar 28, 2025 | ALNY FDA Decision
- IZERVAY Approved Feb 13, 2025 | ALPMY FDA Decision
- PADCEV Approved Nov 21, 2025 | ALPMY FDA Decision
- SELARSDI Approved May 5, 2025 | ALVO FDA Decision
- LUMAKRAS Approved Jan 17, 2025 | AMGN FDA Decision
- UPLIZNA Approved Apr 3, 2025 | AMGN FDA Decision
- TEZSPIRE Approved Oct 17, 2025 | AMGN FDA Decision
- Tarlatamab Approved Nov 19, 2025 | AMGN FDA Decision
- UPLIZNA Approved Dec 11, 2025 | AMGN FDA Decision
- Repatha (evolocumab) - cardiovascular risk Approved Oct 9, 2026 | AMGN FDA Decision
- Iron Sucrose Injection Approved Aug 11, 2025 | AMPH FDA Decision
- Teriparatide injection, USP 560 mcg/2.24 Approved Dec 15, 2025 | AMPH FDA Decision
- Ipratropium Bromide HFA Inhalation Aerosol Approved Feb 24, 2026 | AMPH FDA Decision
- Albuterol sulfate inhalation Approved Dec 2, 2025 | AMRN FDA Decision
- Everolimus Approved Jan 23, 2025 | AMRX FDA Decision
- Brekiya Approved May 15, 2025 | AMRX FDA Decision
- Risperidone Extended Approved Sep 4, 2025 | AMRX FDA Decision
- Sodium oxybate oral solution 500 mg/mL Approved Sep 11, 2025 | AMRX FDA Decision
- Bimatoprost ophthalmic solution Approved Sep 23, 2025 | AMRX FDA Decision
- Iohexol injection Approved Nov 13, 2025 | AMRX FDA Decision
- Oziltus Approved Dec 22, 2025 | AMRX FDA Decision
- Romidepsin injection solution Approved Jun 4, 2026 | AMRX FDA Decision
- Prucalopride Tablets Approved Jan 2, 2025 | ANIP FDA Decision
- ILUVIEN Approved Mar 14, 2025 | ANIP FDA Decision
- Isosorbide Mononitrate Tablet USP Approved Apr 8, 2026 | ANIP FDA Decision
- Penpulimab Approved Apr 23, 2025 | ANTE FDA Decision
- EMPAVELI Approved Jul 28, 2025 | APLS FDA Decision
- VYVGART Hytrulo Approved Apr 10, 2025 | ARGX FDA Decision
- VYVGART Approved May 8, 2026 | ARGX FDA Decision
- ZORYVE Approved May 22, 2025 | ARQT FDA Decision
- ZORYVE Approved Oct 6, 2025 | ARQT FDA Decision
- ZORYVE (roflumilast) Cream 0.3% Approved Jun 29, 2026 | ARQT FDA Decision
- VEPPANU (vepdegestrant) Approved May 1, 2026 | ARVN FDA Decision
- REDEMPLO Approved Nov 18, 2025 | ARWR FDA Decision
- SKYTROFA Approved Jul 28, 2025 | ASND FDA Decision
- YUVIWEL (navepegritide) Approved Feb 27, 2026 | ASND FDA Decision
- TransCon CNP Approved Feb 28, 2026 | ASND FDA Decision
- ATRA FDA Decision: CRL Jan 16, 2025
- Avance Nerve Graf Approved Dec 4, 2025 | AXGN FDA Decision
- SYMBRAVO Approved Jan 30, 2025 | AXSM FDA Decision
- AUVELITY Approved Apr 30, 2026 | AXSM FDA Decision
- Datopotamab Deruxtecan Approved Jan 17, 2025 | AZN FDA Decision
- Enhertu Approved Jan 27, 2025 | AZN FDA Decision
- IMFINZI Approved Mar 31, 2025 | AZN FDA Decision
- DATROWAY Approved Jun 23, 2025 | AZN FDA Decision
- TEZSPIRE Approved Oct 17, 2025 | AZN FDA Decision
- Koselugo Approved Nov 20, 2025 | AZN FDA Decision
- Imfinzi Approved Nov 25, 2025 | AZN FDA Decision
- Enhertu Approved Dec 15, 2025 | AZN FDA Decision
- SAPHNELO (anifrolumab-fnia) Approved Apr 24, 2026 | AZN FDA Decision
- BREZTRI AEROSPHERE Approved Apr 27, 2026 | AZN FDA Decision
- ENHERTU (trastuzumab deruxtecan) Approved May 15, 2026 | AZN FDA Decision
- BAXFENDY (baxdrostat) Approved May 15, 2026 | AZN FDA Decision
- Datopotamab Deruxtecan (Dato-DXd) Approved May 22, 2026 | AZN FDA Decision
- Imfinzi (durvalumab) Approved May 28, 2026 | AZN FDA Decision
- Truqap Approved Jun 12, 2026 | AZN FDA Decision
- Etcamah (camizestrant) Approved Sep 4, 2026 | AZN FDA Decision
- Ultomiris - IgA nephropathy Approved Oct 21, 2026 for IgA Nephropathy | AZN FDA Decision
- Lynkuet Approved Oct 24, 2025 | BAYRY FDA Decision
- HYRNUO Approved Nov 20, 2025 | BAYRY FDA Decision
- AMBELVIST (gadoquatrane) Approved Jun 12, 2026 | BAYRY FDA Decision
- HYRNUO (sevabertinib) - HER2-mutant NSCLC Approved Sep 9, 2026 | BAYRY FDA Decision
- KERENDIA (finerenone), T1D-CKD Approved Sep 16, 2026 | BAYRY FDA Decision
- Sunharbo Approved Nov 9, 2026 for Secondary Stroke Prevention | BAYRY FDA Decision
- Mecbotamab Vedotin Approved Nov 7, 2025 | BCAB FDA Decision
- ORLADEYO Approved Dec 12, 2025 | BCRX FDA Decision
- Ameluz Approved Sep 9, 2026, 19 Days Early | BFRI FDA Decision
- LEQEMBI Approved Jan 26, 2025 | BIIB FDA Decision
- LEQEMBI IQLIK Approved Aug 29, 2025 | BIIB FDA Decision
- SPINRAZA (Nusinersen) Approved Mar 27, 2026 | BIIB FDA Decision
- LEQEMBI IQLIK (lecanemab-irmb) Approved Jul 13, 2026 | BIIB FDA Decision
- PALYNZIQ (pegvaliase-pqpz) Approved Feb 27, 2026 | BMRN FDA Decision
- Opdivo Approved Apr 8, 2025 | BMY FDA Decision
- Opdivo Approved Apr 11, 2025 | BMY FDA Decision
- Sotyktu (deucravacitinib) Approved Mar 6, 2026 | BMY FDA Decision
- Opdivo in combination with AVD Approved Mar 20, 2026 | BMY FDA Decision
- iberdomide Approved Aug 13, 2026, 4 Days Early | BMY FDA Decision
- Camzyos (mavacamten) - pediatric oHCM Approved Sep 30, 2026 | BMY FDA Decision
- COMIRNATY LP.8.1 Approved Aug 27, 2025 | BNTX FDA Decision
- CAPR FDA Decision: CRL Jul 11, 2025
- Gedatolisib with Fulvestrant Approved Jul 14, 2026, 3 Days Early | CELC FDA Decision
- CTx-1301 (fixed dose, pediatric study) CRL Jun 2, 2026 | CING FDA Decision
- Relacorilant + nab-paclitaxel Approved Mar 25, 2026, 108 Days Early | CORT FDA Decision
- PALSONIFY Approved Sep 25, 2025 | CRNX FDA Decision
- Casgevy (exagamglogene autotemcel) Approved Jul 1, 2026 | CRSP FDA Decision
- Garadacimab Approved Jun 17, 2025 | CSLLY FDA Decision
- MYQORZO Approved Dec 19, 2025 | CYTK FDA Decision
- AVLAYAH (Tividenofusp alfa) Approved Mar 24, 2026 | DNLI FDA Decision
- Enhertu Approved Jan 27, 2025 | DSNKY FDA Decision
- Enhertu Approved Dec 15, 2025 | DSNKY FDA Decision
- OTC NARCAN Nasal Spray Approved Jan 14, 2026 | EBS FDA Decision
- OTC NARCAN Nasal Spray - 6-count and 24-count Approved Feb 12, 2026 | EBS FDA Decision
- ENGN FDA Decision: CRL Nov 11, 2025
- MAVYRET Approved Jun 11, 2025 | ENTA FDA Decision
- EQ FDA Decision: CRL Mar 27, 2025
- ESLA FDA Decision: CRL Nov 3, 2025
- KHINDIVI Approved May 29, 2025 | ETON FDA Decision
- ETON FDA Decision: Approved Feb 25, 2026
- CABOMETYX Approved Mar 26, 2025 | EXEL FDA Decision
- Zegfrovy Approved Jul 2, 2025 | EXEL FDA Decision
- ZYCUBO Approved Jan 13, 2026 | FBIO FDA Decision
- Yeztugo Approved Jun 18, 2025 | GILD FDA Decision
- Exdensur Approved Dec 16, 2025 | GILD FDA Decision
- Yescarta (axicabtagene ciloleucel) Approved Feb 6, 2026 | GILD FDA Decision
- Hepcludex (Bulevirtide) Approved May 22, 2026 | GILD FDA Decision
- Trodelvy (sacituzumab govitecan-hziy) Approved Jun 24, 2026 | GILD FDA Decision
- Bictegravir and Lenacapavir Approved Aug 27, 2026 | GILD FDA Decision
- Epioxa Approved Oct 20, 2025 | GKOS FDA Decision
- IDose TR Approved Jan 28, 2026 | GKOS FDA Decision
- EPKINLY Approved Nov 18, 2025 | GMAB FDA Decision
- GTX-104 CRL Apr 23, 2026 | GRCE FDA Decision
- Blujepa Approved Mar 25, 2025 | GSK FDA Decision
- Nucala Approved May 22, 2025 | GSK FDA Decision
- Benlysta Approved Jun 24, 2025 | GSK FDA Decision
- Shingrix Approved Jul 17, 2025 | GSK FDA Decision
- Blenrep Approved Oct 23, 2025 | GSK FDA Decision
- Blujepa Approved Dec 11, 2025 | GSK FDA Decision
- Arexvy Approved Mar 13, 2026 | GSK FDA Decision
- Linerixibat Approved Mar 17, 2026 | GSK FDA Decision
- Tebipenem HBr (SPR994) Approved Jun 17, 2026, 1 Day Early | GSK FDA Decision
- Jemperli Approved Oct 19, 2026 for Locally Advanced Rectal Cancer | GSK FDA Decision
- Hibsago Approved Oct 20, 2026, 6 Days Early for Chronic Hepatitis B | GSK FDA Decision
- VYVGART Hytrulo Approved Apr 10, 2025 | HALO FDA Decision
- TECVAYLI (teclistamab-cqyv) Approved Mar 5, 2026 | HALO FDA Decision
- Andembry Approved Jun 16, 2025 | HOTH FDA Decision
- WAKIX (pitolisant) Approved Feb 13, 2026 | HRMY FDA Decision
- ANKTIVA Approved Feb 19, 2025 | IBRX FDA Decision
- IBRX FDA Decision: CRL Jan 16, 2026
- ANKTIVA (N-803) + BCG Approved Oct 14, 2026, 84 Days Early | IBRX FDA Decision
- Zynyz Approved May 15, 2025 | INCY FDA Decision
- MONJUVI Approved Jun 18, 2025 | INCY FDA Decision
- Opzelura Approved Sep 19, 2025 | INCY FDA Decision
- ZYNYZ (retifanlimab-dlwr) CRL Apr 8, 2026 | INCY FDA Decision
- Jakafi XR (ruxolitinib) Approved May 1, 2026 | INCY FDA Decision
- Atebrioz (zilurgisertib) Approved Sep 25, 2026, 1 Day Early | INCY FDA Decision
- SUBLOCADE Approved Feb 24, 2025 | INDV FDA Decision
- VOCERYQ (INO-3107) Approved Oct 30, 2026 | INO FDA Decision
- BRINSUPRI Approved Aug 12, 2025 | INSM FDA Decision
- Qfitlia Approved Mar 28, 2025 | INTE FDA Decision
- NUZOLVENCE Approved Dec 15, 2025 | INVA FDA Decision
- INVA FDA Decision: Approved Feb 17, 2026
- Dawnzera Approved Aug 21, 2025 | IONI FDA Decision
- DAWNZERA Approved Aug 21, 2025 | IONS FDA Decision
- SPINRAZA (Nusinersen) Approved Mar 27, 2026 | IONS FDA Decision
- Olezarsen Approved Jun 24, 2026, 6 Days Early | IONS FDA Decision
- Zilganersen (ION373) Approved Sep 3, 2026, 19 Days Early | IONS FDA Decision
- CABOMETYX Approved Mar 26, 2025 | IPSEY FDA Decision
- RYZUMVI Approved Oct 16, 2026, 1 Day Early for Presbyopia | IRD FDA Decision
- Bitopertin Approved Jan 21, 2025 | IRON FDA Decision
- Bitopertin CRL Feb 13, 2026 | IRON FDA Decision
- Apraglutide Approved Apr 14, 2025 | IRWD FDA Decision
- LINZESS (Iinaclotide) Approved May 27, 2026 | IRWD FDA Decision
- Dordaviprone Approved Aug 6, 2025 | JAZZ FDA Decision
- Zepzelca Approved Oct 2, 2025 | JAZZ FDA Decision
- Ziihera (zanidatamab-hrii) Approved Aug 25, 2026 | JAZZ FDA Decision
- SPRAVATO Approved Jan 21, 2025 | JNJ FDA Decision
- TREMFYA Approved Mar 20, 2025 | JNJ FDA Decision
- IMAAVY Approved Apr 30, 2025 | JNJ FDA Decision
- INLEXZO Approved Sep 9, 2025 | JNJ FDA Decision
- TREMFYA Approved Sep 19, 2025 | JNJ FDA Decision
- TREMFYA Approved Sep 29, 2025 | JNJ FDA Decision
- CAPLYTA Approved Nov 6, 2025 | JNJ FDA Decision
- DARZALEX FASPRO Approved Nov 7, 2025 | JNJ FDA Decision
- AKEEGA Approved Dec 15, 2025 | JNJ FDA Decision
- RYBREVANT FASPRO Approved Dec 18, 2025 | JNJ FDA Decision
- DARZALEX FASPRO Approved Jan 27, 2026 | JNJ FDA Decision
- TECVAYLI (teclistamab-cqyv) Approved Mar 5, 2026 | JNJ FDA Decision
- ICOTYDE (icotrokinra) Approved Mar 17, 2026 | JNJ FDA Decision
- TREMFYA (guselkumab) Approved May 28, 2026 | JNJ FDA Decision
- JSPR FDA Decision: CRL Jan 8, 2025
- JSPR FDA Decision: CRL Jul 7, 2025
- EKTERLY Approved Jul 7, 2025 | KALV FDA Decision
- KOMZIFTI Approved Nov 13, 2025 | KURA FDA Decision
- Paxalisib Approved Jan 2, 2025 | KZIA FDA Decision
- VIZZ Approved Jul 31, 2025 | LENZ FDA Decision
- DehydraTECH Approved Jan 15, 2025 | LEXX FDA Decision
- FILSPARI Approved Aug 27, 2025 | LGND FDA Decision
- FILSPARI (sparsentan) Approved Apr 13, 2026 | LGND FDA Decision
- Omvoh Approved Jan 15, 2025 | LLY FDA Decision
- Inluriyo Approved Sep 25, 2025 | LLY FDA Decision
- Omvoh Approved Oct 27, 2025 | LLY FDA Decision
- Jaypirca Approved Dec 3, 2025 | LLY FDA Decision
- Foundayo (orforglipron) Approved Apr 1, 2026 | LLY FDA Decision
- EBGLYSS (lebrikizumab-lbkz) Approved Jun 9, 2026 | LLY FDA Decision
- Mounjaro (tirzepatide) Approved Aug 27, 2026 | LLY FDA Decision
- Inluriyo (imlunestrant) + Verzenio Approved Sep 18, 2026 | LLY FDA Decision
- Onswik (insulin efsitora alfa-gobe) Approved Sep 23, 2026 | LLY FDA Decision
- Olumiant (baricitinib) Approved Sep 25, 2026 | LLY FDA Decision
- Jaypirca (pirtobrutinib) Approved Oct 2, 2026 for First-Line CLL/SLL | LLY FDA Decision
- PYLARIFY TruVu (piflufolastat F 18) Approved Mar 6, 2026 | LNTH FDA Decision
- LNTH-2501 (Gallium-68 edotreotide) CRL Jun 26, 2026 | LNTH FDA Decision
- MK-6240 Approved Aug 13, 2026 | LNTH FDA Decision
- YUTREPIA Approved May 23, 2025 | LQDA FDA Decision
- LSTA FDA Decision: CRL Jan 22, 2025
- ZYNYZ (retifanlimab-dlwr) CRL Apr 8, 2026 | MGNX FDA Decision
- CTEXLI Approved Feb 24, 2025 | MIRM FDA Decision
- LIVMARLI Approved Apr 14, 2025 | MIRM FDA Decision
- Atebrioz (zilurgisertib) Approved Sep 25, 2026, 1 Day Early | MIRM FDA Decision
- MIST FDA Decision: CRL Mar 28, 2025
- CARDAMYST Approved Dec 15, 2025 | MIST FDA Decision
- Pimjetmi Approved Nov 10, 2026 for Tenosynovial Giant Cell Tumor | MKKGY FDA Decision
- Afrezza (Technosphere Insulin) Approved May 29, 2026 | MNKD FDA Decision
- FUROSCIX ReadyFlow Autoinjector Approved Jul 23, 2026, 3 Days Early | MNKD FDA Decision
- WELIREG Approved May 14, 2025 | MRK FDA Decision
- KEYTRUDA Approved Jun 13, 2025 | MRK FDA Decision
- KEYTRUDA QLEX Approved Sep 19, 2025 | MRK FDA Decision
- WINREVAIR Approved Oct 27, 2025 | MRK FDA Decision
- PADCEV Approved Nov 21, 2025 | MRK FDA Decision
- KEYTRUDA and KEYTRUDA QLEX Approved Feb 11, 2026 | MRK FDA Decision
- KEYTRUDA + chemo ± bevacizumab Approved Feb 20, 2026 | MRK FDA Decision
- IDVYNSO (doravirine/islatravir) Approved Apr 20, 2026 | MRK FDA Decision
- KEYTRUDA (pembrolizumab) Approved Jun 12, 2026 | MRK FDA Decision
- CAPVAXIVE Approved Jun 18, 2026 | MRK FDA Decision
- Trodelvy (sacituzumab govitecan-hziy) Approved Jun 24, 2026 | MRK FDA Decision
- KEYTRUDA (pembrolizumab) plus Padcev Approved Jul 10, 2026 | MRK FDA Decision
- Lipfendra (enlicitide decanoate) Approved Jul 15, 2026 | MRK FDA Decision
- WINREVAIR (sotatercept-csrk) Approved Sep 21, 2026, On Goal Date | MRK FDA Decision
- Welireg (belzutifan) plus Lenvima (lenvatinib) Approved Sep 24, 2026 | MRK FDA Decision
- MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) Approved Aug 5, 2026 | MRNA FDA Decision
- IBTROZI Approved Jun 11, 2025 | NUVB FDA Decision
- IBTROZI (taletrectinib) sNDA Approved Sep 16, 2026, 110 Days Early | NUVB FDA Decision
- Zidesamtinib (NVL-520) Approved Jul 22, 2026, 58 Days Early | NUVL FDA Decision
- NUVAXOVID Approved May 19, 2025 | NVAX FDA Decision
- Nuvaxovid Approved Aug 27, 2025 | NVAX FDA Decision
- Optune Pax (Tumor Treating Fields) Approved Feb 11, 2026 | NVCR FDA Decision
- NVCR FDA Decision (Nov 9, 2026): Optune Mya: Not approvable letter
- Wegovy Approved Aug 15, 2025 | NVO FDA Decision
- Rybelsus Approved Oct 15, 2025 | NVO FDA Decision
- Wegovy pill Approved Dec 22, 2025 | NVO FDA Decision
- Sogroya (somapacitan) Approved Mar 3, 2026 | NVO FDA Decision
- Wegovy HD Approved Mar 19, 2026 | NVO FDA Decision
- Awiqli (insulin icodec-abae) Approved Mar 26, 2026 | NVO FDA Decision
- Fabhalta Approved Mar 20, 2025 | NVS FDA Decision
- Pluvicto Approved Mar 28, 2025 | NVS FDA Decision
- Vanrafia Approved Apr 3, 2025 | NVS FDA Decision
- MONJUVI Approved Jun 18, 2025 | NVS FDA Decision
- Rhapsido Approved Sep 30, 2025 | NVS FDA Decision
- Itvisma Approved Nov 24, 2025 | NVS FDA Decision
- COSENTYX (secukinumab) Approved Mar 12, 2026 | NVS FDA Decision
- Pluvicto Approved Jul 31, 2026 | NVS FDA Decision
- Rhapsido (remibrutinib) Approved Oct 6, 2026 for Dermographism | NVS FDA Decision
- POHERDY Approved Nov 17, 2025 | OGN FDA Decision
- YARTEMLEA Approved Dec 24, 2025 | OMER FDA Decision
- BEQALZI (Sonrotoclax) Approved May 13, 2026 | ONC FDA Decision
- OTLK FDA Decision: CRL Aug 28, 2025
- LYTENAVA CRL Dec 31, 2025 | OTLK FDA Decision
- LYTENAVA (bevacizumab-vikg) CRL Mar 5, 2026 | OTLK FDA Decision
- LYTENAVA (bevacizumab-vikg) CRL Apr 7, 2026 | OTLK FDA Decision
- bevacizumab Approved Jul 24, 2026, 5 Days Early | OTLK FDA Decision
- Centanafadine Approved Jul 24, 2026 | OTSKY FDA Decision
- ADCETRIS Approved Feb 12, 2025 | PFE FDA Decision
- PADCEV Approved Nov 21, 2025 | PFE FDA Decision
- BRAFTOVI (encorafenib) Approved Feb 24, 2026 | PFE FDA Decision
- VEPPANU (vepdegestrant) Approved May 1, 2026 | PFE FDA Decision
- HYMPAVZI (marstacimab) Approved Jun 5, 2026 | PFE FDA Decision
- IBRANCE (palbociclib) Approved Jun 24, 2026 | PFE FDA Decision
- KEYTRUDA (pembrolizumab) plus Padcev Approved Jul 10, 2026 | PFE FDA Decision
- Brepocitinib (VALOR) Approved Aug 27, 2026 | PFE FDA Decision
- Tukysa (tucatinib) + trastuzumab + pertuzumab Approved Oct 7, 2026 | PFE FDA Decision
- PAPZIMEOS Approved Aug 15, 2025 | PGEN FDA Decision
- PHAR FDA Decision: CRL Feb 1, 2026
- Joenja (leniolisib) Approved Sep 11, 2026, 43 Days Early | PHAR FDA Decision
- PHIO FDA Decision: CRL Jan 13, 2025
- KETARX Approved Aug 11, 2025 | PHRRF FDA Decision
- SEPHIENCE Approved Jul 28, 2025 | PTCT FDA Decision
- ICOTYDE (icotrokinra) Approved Mar 17, 2026 | PTGX FDA Decision
- Rusfertide Approved Aug 28, 2026 | PTGX FDA Decision
- UX111 CRL Jul 11, 2025 | RARE FDA Decision
- DTX401 AAV gene therapy Approved Aug 19, 2026, 4 Days Early | RARE FDA Decision
- FAYUVI Approved Sep 17, 2026, 2 Days Early | RARE FDA Decision
- KRESLADI (marnetegragene autotemcel) Approved Mar 27, 2026 | RCKT FDA Decision
- Dupixent Approved Apr 18, 2025 | REGN FDA Decision
- EYLEA HD CRL Apr 20, 2025 | REGN FDA Decision
- Lynozyfic Approved Jul 2, 2025 | REGN FDA Decision
- Libtayo Approved Oct 8, 2025 | REGN FDA Decision
- Solnerstotug CRL Oct 17, 2025 | REGN FDA Decision
- EYLEA HD Approved Nov 19, 2025 | REGN FDA Decision
- EYLEA HD (aflibercept) Approved Apr 2, 2026 | REGN FDA Decision
- DUPIXENT (dupilumab) Approved Apr 22, 2026 | REGN FDA Decision
- Otarmeni (lunsotogene parvec-cwha) Approved Apr 23, 2026 | REGN FDA Decision
- Garetosmab Approved Aug 19, 2026 | REGN FDA Decision
- REPL FDA Decision: CRL Jul 22, 2025
- RP1 (vusolimogene oderparepvec) CRL Apr 10, 2026 | REPL FDA Decision
- TUDRIQEV Approved Aug 6, 2026, 4 Days Late | REPL FDA Decision
- clemidsogene lanparvovec (RGX-121) CRL Feb 9, 2026 | RGNX FDA Decision
- Susvimo Approved Feb 4, 2025 | RHHBY FDA Decision
- EVRYSDI Approved Feb 12, 2025 | RHHBY FDA Decision
- TNKase Approved Mar 3, 2025 | RHHBY FDA Decision
- Susvimo Approved May 22, 2025 | RHHBY FDA Decision
- Zepzelca Approved Oct 2, 2025 | RHHBY FDA Decision
- Lunsumio VELO Approved Dec 22, 2025 | RHHBY FDA Decision
- CALQUENCE plus venetoclax Approved Feb 20, 2026 | RHHBY FDA Decision
- Gazyva (obinutuzumab) Approved Sep 25, 2026 | RHHBY FDA Decision
- Tecentriq Approved Oct 8, 2026, 1 Day Early for dMMR Colon Cancer | RHHBY FDA Decision
- Enspryng Approved Oct 15, 2026 for Thyroid Eye Disease | RHHBY FDA Decision
- TTX Approved Feb 6, 2025 | RNAZ FDA Decision
- TTX Approved Mar 13, 2025 | RNAZ FDA Decision
- Brepocitinib Approved Aug 27, 2026 | ROIV FDA Decision
- Rasonque (daraxonrasib) Approved Aug 26, 2026 | RVMD FDA Decision
- IMCIVREE (setmelanotide) Approved Mar 19, 2026 | RYTM FDA Decision
- VYKAT XR Approved Mar 26, 2025 | SLNO FDA Decision
- Revuforj Approved Oct 24, 2025 | SNDX FDA Decision
- SNSE FDA Decision: CRL Oct 17, 2025
- Qfitlia Approved Mar 28, 2025 | SNY FDA Decision
- Dupixent Approved Apr 18, 2025 | SNY FDA Decision
- DUPIXENT Approved Jun 2, 2025 | SNY FDA Decision
- Wayrilz Approved Aug 29, 2025 | SNY FDA Decision
- Tolebrutinib CRL Dec 28, 2025 | SNY FDA Decision
- SNY FDA Decision: Approved Feb 24, 2026
- DUPIXENT (dupilumab) Approved Apr 22, 2026 | SNY FDA Decision
- Tebipenem HBr (SPR994) Approved Jun 17, 2026, 1 Day Early | SPRO FDA Decision
- Neffy 1 mg Approved Mar 5, 2025 | SPRY FDA Decision
- neffy (epinephrine nasal spray) Approved Mar 26, 2026 | SPRY FDA Decision
- Apitegromab CRL Sep 23, 2025 | SRRK FDA Decision
- ISEMBYLD (apitegromab-mstn) Approved Sep 11, 2026, 19 Days Early | SRRK FDA Decision
- ONAPGO Approved Feb 4, 2025 | SUPN FDA Decision
- SVRA FDA Decision: CRL May 27, 2025
- GOMEKLI Approved Feb 11, 2025 | SWTX FDA Decision
- GAMMAGARD LIQUID ERC Approved Jun 30, 2025 | TAK FDA Decision
- Oveporexton (TAK-861-2001) Approved Aug 5, 2026 | TAK FDA Decision
- SELARSDI Approved May 5, 2025 | TEVA FDA Decision
- AJOVY Approved Aug 6, 2025 | TEVA FDA Decision
- UZEDY Approved Oct 10, 2025 | TEVA FDA Decision
- PONLIMSI (denosumab-adet) Approved Mar 27, 2026 | TEVA FDA Decision
- Degevma (denosumab-adet) Approved Sep 25, 2026 | TEVA FDA Decision
- Weltruza (olanzapine) extended-release Approved Oct 8, 2026 | TEVA FDA Decision
- Gozellix Approved Mar 21, 2025 | TLX FDA Decision
- TLX101 CRL Apr 28, 2025 | TLX FDA Decision
- Pixclara Approved Sep 11, 2026, On Goal Date | TLX FDA Decision
- Tonmya Approved Aug 15, 2025 | TNXP FDA Decision
- TRAW FDA Decision: CRL Jun 3, 2025
- Romvimza Approved Feb 14, 2025 | TURN FDA Decision
- FILSPARI Approved Aug 27, 2025 | TVTX FDA Decision
- FILSPARI (sparsentan) Approved Apr 13, 2026 | TVTX FDA Decision
- UNCY FDA Decision: CRL Jun 30, 2025
- Oxylanthanum Carbonate (OLC) CRL Jun 29, 2026 | UNCY FDA Decision
- ZUSDURI Approved Jun 12, 2025 | URGN FDA Decision
- Atacicept Approved Jul 7, 2026 | VERA FDA Decision
- NEREUS Approved Dec 30, 2025 | VNDA FDA Decision
- Bysanti (milsaperidone) Approved Feb 20, 2026 | VNDA FDA Decision
- Bysanti Approved Feb 21, 2026 | VNDA FDA Decision
- Veligrotug (VRDN-001) Approved Jun 26, 2026, 4 Days Early | VRDN FDA Decision
- Suzetrigine Approved Jan 30, 2025 | VRTX FDA Decision
- Casgevy (exagamglogene autotemcel) Approved Jul 1, 2026 | VRTX FDA Decision
- AVMAPKI FAKZYNJA CO Approved May 8, 2025 | VSTM FDA Decision
- MR-100A-01 Approved Jul 28, 2026, 2 Days Early | VTRS FDA Decision
- RYZUMVI Approved Oct 16, 2026, 1 Day Early for Presbyopia | VTRS FDA Decision
- WVE Approved Mar 26, 2025 | WVE FDA Decision
- Gvoke VialDx Approved Mar 17, 2025 | XERS FDA Decision
- MONJUVI Approved Jun 18, 2025 | XNCR FDA Decision
- XRx Approved Apr 30, 2025 | XRTX FDA Decision
- Ziihera (zanidatamab-hrii) Approved Aug 25, 2026 | ZYME FDA Decision
Learn · 9
FDA decision dates (event pages) · 176
- ABBV FDA Decision History and PDUFA Dates
- ABBV PDUFA date: RINVOQ
- ABBV FDA decision: JUVMO (Tavapadon), Approved September 25, 2026
- ABEO FDA decision: FAYUVI, Approved September 17, 2026
- AGIO PDUFA Date 2026-11-01: Mitapivat (PYRUKYND) - (RISE UP)
- AGIO PDUFA date: Mitapivat, Feb 1, 2027
- ANAB PDUFA date: ANB019, Dec 12 2026
- APMD PDUFA Dates: AD109 (Oxnimbi) - obstructive sleep apne & History
- APMD PDUFA date: AD109, Feb 28, 2027
- AQST PDUFA Dates: Anaphylm (dibutepinephrine) sublingual f & History
- AQST PDUFA date: Anaphylm, Mar 16, 2027
- ARQT PDUFA Dates: ZORYVE (roflumilast) cream 0.05% & History
- ARQT PDUFA date: ZORYVE, Feb 23, 2027
- AXSM PDUFA Dates: AXS-12 & History
- AXSM PDUFA date: AXS-12, May 1, 2027
- AZN FDA Decision History and PDUFA Dates
- AZN FDA decision: Etcamah (camizestrant), Approved September 4, 2026
- AZN FDA decision: Enhertu, Approved May 15, 2026
- AZN PDUFA date: Gefurulimab
- AZN FDA decision: Ultomiris, Approved October 21, 2026
- BAYRY FDA Decision History and PDUFA Dates
- BAYRY FDA decision: HYRNUO, Approved September 9, 2026
- BAYRY FDA decision: KERENDIA, Approved September 16, 2026
- BAYRY FDA decision: HYRNUO (sevabertinib), Approved September 9, 2026
- BBIO PDUFA date: BBP-418, Nov 27 2026
- BBIO PDUFA date: BBP-418, Nov 27, 2026
- BBIO PDUFA date: Encaleret, May 8, 2027
- BBIO PDUFA date: Oral infigratinib, Feb 4, 2027
- BFRI FDA decision: Ameluz, Approved September 9, 2026
- BIIB FDA decision: LEQEMBI IQLIK, Approved July 13, 2026
- BLTE PDUFA Dates: Tinlarebant - Stargardt disease type 1 & History
- BLTE PDUFA date: Tinlarebant, Feb 12, 2027
- BMRN PDUFA Dates: VOXZOGO (vosoritide) - full approval, ch & History
- BMRN PDUFA date: VOXZOGO, Feb 28, 2027
- BMRN PDUFA date: VOXZOGO, May 30, 2027
- BMY PDUFA Dates: Reblozyl (luspatercept) with a JAK inhib & History
- BMY PDUFA date: Mezigdomide, May 13, 2027
- BMY PDUFA date: Reblozyl, Mar 11, 2027
- BTAI PDUFA date: IGALMI®, Nov 14 2026
- CAPR PDUFA date: CAP-1002, Nov 22 2026
- CAPR PDUFA date: Deramiocel, Nov 22, 2026
- CGEM PDUFA Date 2027-02-27: CLN-081
- CGEM PDUFA date: Zipalertinib, Feb 27, 2027
- COGT PDUFA date: Bezuclastinib, Dec 30 2026
- COGT PDUFA date: Bezuclastinib, Nov 30, 2026
- COGT PDUFA date: Bezuclastinib, Jun 29, 2027
- COGT PDUFA date: Bezuclastinib, Dec 30, 2026
- COGT PDUFA date: Bezuclastinib, Dec 30, 2026
- CORT PDUFA Dates: Relacorilant - (GRACE resubmission) & History
- CORT PDUFA date: Relacorilant, Dec 17, 2026
- CYTK PDUFA Dates: Aficamten - (MAPLE-HCM) & History
- CYTK PDUFA date: Aficamten, Nov 14, 2026
- DYN PDUFA Dates: Z-rostudirsen - Duchenne muscular dystro & History
- DYN PDUFA date: Z-rostudirsen, Jan 21, 2027
- ETON PDUFA Dates: LIBERVANT (diazepam) buccal film - ages & History
- ETON PDUFA date: LIBERVANT, Mar 29, 2027
- EXEL PDUFA date: XL092 with atezolizumab, Mar 3 2027
- EXEL PDUFA date: Zanzalintinib, Mar 3, 2027
- GILD PDUFA Dates: Anito-cel (anitocabtagene autoleucel) & History
- GILD PDUFA date: Anito-cel, Dec 23, 2026
- GILD FDA decision: Bictegravir and Lenacapavir, Approved August 27, 2026
- GILD FDA decision: Trodelvy, Approved June 24, 2026
- GILD PDUFA date: Yeztugo, Feb 2, 2027
- GSK PDUFA Dates: Neladalkib (NVL-655) - (ALKOVE-1) & History
- GSK FDA decision: Hibsago (Bepirovirsen), Approved October 20, 2026
- GSK PDUFA date: Neladalkib, Nov 2026
- HRMY PDUFA Dates: Pitolisant GR (gastro-resistant formulat & History
- HRMY PDUFA date: Pitolisant GR, Apr 1, 2027
- IBRX FDA Decision History and PDUFA Dates
- IBRX FDA decision: ANKTIVA, Approved October 14, 2026
- IMNM PDUFA Dates: Varegacestat - desmoid tumors (RINGSIDE) & History
- IMNM PDUFA date: Varegacestat, Apr 28, 2027
- INBX PDUFA Dates: Ozekibart (INBRX-109) - conventional cho & History
- INBX PDUFA date: Ozekibart, Apr 14, 2027
- INCY PDUFA Date 2026-09-26: zilurgisertib
- INCY FDA decision: Atebrioz, Approved September 25, 2026
- INO FDA decision: Voceryq (INO-3107), Approved October 30, 2026
- INO FDA decision: Voceryq (INO-3107 DNA), Approved October 30, 2026
- INSM PDUFA Dates: ARIKAYCE (amikacin liposome inhalation s & History
- INSM PDUFA date: ARIKAYCE, Jan 28, 2027
- IONS FDA Decision History and PDUFA Dates
- IONS FDA decision: Zanvastro (zilganersen), Approved September 3, 2026
- IRD / VTRS FDA decision: RYZUMVI (phentolamine), Approved October 16, 2026
- JAZZ PDUFA Dates: Cannabidiol oral capsule formulation (ND & History
- JAZZ PDUFA date: Cannabidiol oral, Apr 16, 2027
- LLY FDA decision: Mounjaro (tirzepatide), Approved August 27, 2026
- LNTH FDA Decision History and PDUFA Dates
- LNTH FDA decision: TAUKLARIFY (florquinitau), Approved August 13, 2026
- MIRM FDA Decision History and PDUFA Dates
- MIRM FDA decision: Atebrioz, Approved September 25, 2026
- MLYS PDUFA date: Lorundrostat, Dec 22 2026
- MLYS PDUFA date: lorundrostat, Dec 22, 2026
- MRK PDUFA Dates: ENFLONSIA (clesrovimab) - second RSV sea & History
- MRK PDUFA date: ENFLONSIA, Mar 22, 2027
- MRK PDUFA date: IDVYNSO, Apr 22, 2027
- MRK ifinatamab deruxtecan BLA withdrawn Sep 25, 2026, before Oct 10, 2026 PDUFA date
- MRK FDA decision: KEYTRUDA, Approved July 10, 2026
- MRK PDUFA date: Sacituzumab tirumotecan, Jun 15, 2027
- MRK FDA decision: Trodelvy, Approved June 24, 2026
- MRK FDA decision: WINREVAIR, Approved September 21, 2026
- MRNA FDA decision: mRNA-1010, Approved August 5, 2026
- NRXP FDA goal date (ANDA): KETAFREE, Jul 29 2026
- NTLA PDUFA Dates: Lonvoguran ziclumeran (lonvo-z) - heredi & History
- NTLA PDUFA date: Lonvoguran ziclumeran, Mar 10, 2027
- NUVB FDA Decision History and PDUFA Dates
- NUVB FDA decision: IBTROZI, Approved September 16, 2026
- NUVL FDA Decision History and PDUFA Dates
- GSK (formerly NUVL) PDUFA date: NVL-655, Nov 27 2026
- NUVL FDA decision: JIDEYTRO (zidesamtinib), Approved July 22, 2026
- NVCR FDA Decision History and PDUFA Dates
- NVCR FDA decision: TTFields therapy, Not approvable letter November 9, 2026
- NVO PDUFA Dates: CagriSema (AM833) & History
- CagriSema FDA goal date: not announced (NVO)
- Mim8 FDA goal date: not announced (NVO)
- NVS FDA decision: 177Lu, Approved July 31, 2026
- ONC FDA decision: Ziihera, Approved August 25, 2026
- OTLK PDUFA Date 2026-07-29: bevacizumab
- PFE FDA Decision History and PDUFA Dates
- PFE FDA decision: LISRAYA (brepocitinib), Approved August 27, 2026
- PFE FDA decision: KEYTRUDA, Approved July 10, 2026
- PFE PDUFA: TUKYSA, trastuzumab, and pertuzumab
- PHAR PDUFA Dates: Joenja (leniolisib) lower doses - APDS, & History
- PHAR PDUFA date: Joenja, Jan 30, 2027
- PHVS PDUFA Dates: Deucrictibant IR - (RAPIDe-3) & History
- PHVS PDUFA date: Deucrictibant IR, Apr 23, 2027
- PRAX PDUFA date: PRAX-562, Dec 27 2026
- PRAX PDUFA date: Relutrigine, Dec 27, 2026
- PRAX PDUFA date: ulixacaltamide, Jan 29, 2027
- PTGX FDA decision: MIMRYLO (rusfertide), Approved August 28, 2026
- PVLA PDUFA Dates: QTORIN rapamycin - microcystic lymphatic & History
- PVLA PDUFA date: QTORIN rapamycin, Feb 28, 2027
- PYPD PDUFA Dates: D-PLEX100 - prevention of surgical site & History
- PYPD PDUFA date: D-PLEX100, Nov 28, 2026
- QURE PDUFA Dates: Ifezuntirgene inilparvovec (AMT-130) - H & History
- QURE PDUFA date: Ifezuntirgene inilparvovec, May 1, 2027
- RARE FDA Decision History and PDUFA Dates
- RARE FDA decision: GENGLYCOS (pariglasgene), Approved August 19, 2026
- RARE FDA decision: FAYUVI (UX111), Approved September 17, 2026
- REGN PDUFA Dates: Cemdisiran (C5 RNAi) - (NIMBLE) & History
- REGN PDUFA date: Cemdisiran, Nov 2026
- REGN FDA decision: Pasatru (garetosmab), Approved August 19, 2026
- RHHBY PDUFA Dates: Giredestrant (lidERA) & History
- RHHBY FDA decision: Enspryng (satralizumab), Approved October 15, 2026
- RHHBY PDUFA date: Enspryng, Jan 10, 2027
- RHHBY PDUFA date: Gazyva, December 2026
- RHHBY PDUFA date: Gazyva, November 2026
- RHHBY PDUFA date: Giredestrant, Nov 30 2026
- RHHBY PDUFA date: Giredestrant (evERA, with everolimus), Dec 18, 2026
- RHHBY PDUFA date: Lunsumio VELO, Feb 9, 2027
- RHHBY FDA decision: Tecentriq, Approved October 8, 2026
- ROIV FDA decision: Brepocitinib, Approved August 27, 2026
- RPRX FDA decision: JIDEYTRO (zidesamtinib), Approved July 22, 2026
- SMMT PDUFA: Ivonescimab plus platinum-doublet chemotherapy…
- SMMT PDUFA date: Ivonescimab, Nov 14, 2026
- SRRK FDA Decision History and PDUFA Dates
- SRRK FDA decision: ISEMBYLD (apitegromab), Approved September 11, 2026
- SVRA PDUFA date: Molgradex, Nov 22 2026
- SVRA PDUFA date: MOLBREEVI, Nov 22, 2026
- TAK FDA decision: Oveporexton, Approved August 5, 2026
- TEVA PDUFA Dates: IGALMI (dexmedetomidine sublingual film) & History
- TEVA PDUFA date: IGALMI, Nov 14, 2026
- TLX FDA decision: Pixclara, Approved September 11, 2026
- URGN PDUFA Dates: UGN-103 (mitomycin) - low-grade intermed & History
- URGN PDUFA date: UGN-103, Jun 14, 2027
- VNDA PDUFA date: ANB019, Dec 12 2026
- VNDA PDUFA date: Imsidolimab, Dec 12, 2026
- VRTX PDUFA date: ALPN-303, Nov 30 2026
- VRTX PDUFA date: Povetacicept, Nov 30, 2026
- VSTM PDUFA Dates: AVMAPKI FAKZYNJA CO-PACK blister pack (N & History
- VSTM PDUFA date: AVMAPKI FAKZYNJA, Feb 7, 2027
- VTRS PDUFA Dates: MR-107A-02 (fast-acting meloxicam) & History
- VTRS FDA decision: MR-100A-01, Approved July 28, 2026
- VTRS PDUFA date: MR-107A-02, Dec 27 2026
- ZBIO PDUFA Dates: Obexelimab - IgG4-related disease & History
- ZBIO PDUFA date: Obexelimab, May 27, 2027
- ZYME FDA decision: Ziihera, Approved August 25, 2026
Readouts · 22
Research · 8
Companies · 337
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- AbbVie Inc. (ABBV) FDA Catalysts: JUVMO, JUVMO (tavapadon)
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- Abeona Therapeutics Inc. (ABEO) FDA Catalysts
- Acumen Pharmaceuticals, Inc. (ABOS) FDA Catalysts: sabirnetug
- Acadia Pharmaceuticals INC (ACAD) FDA Catalysts
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- Actuate Therapeutics, Inc. (ACTU) FDA Catalysts: Losartan
- Adagene Inc. (ADAG) FDA Catalysts: ADG106
- ADC Therapeutics SA (ADCT) FDA Catalysts
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- Agenus Inc (AGEN) FDA Catalysts: Balstilimab, Botensilimab
- Agios Pharmaceuticals (AGIO) FDA Catalysts: Mitapivat
- Agomab Therapeutics NV (AGMB) FDA Catalysts: AGMB-129
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- Akebia Therapeutics, Inc. (AKBA) FDA Catalysts: Vadadustat
- Aktis Oncology, Inc. (AKTS) FDA Catalysts: AKY-1189 readout
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- Alnylam Pharmaceuticals, Inc. (ALNY) FDA Catalysts
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- Alvotech (ALVO) FDA Catalysts
- Alzamend Neuro, Inc. (ALZN) FDA Catalysts
- Amgen Inc (AMGN) FDA Catalysts: ABP 938, Tezepelumab
- Amylyx Pharmaceuticals, Inc. (AMLX) FDA Catalysts: Avexitide
- Amphastar Pharmaceuticals Inc. (AMPH) FDA Catalysts
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- Annexon, Inc. (ANNX) FDA Catalysts: Tanruprubart
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- Annovis Bio, Inc. (ANVS) FDA Catalysts: buntanetap/posiphen
- Apogee Therapeutics, Inc. (APGE) FDA Catalysts: APG777
- Apollomics Inc. (APLM) FDA Catalysts: Uproleselan
- APLS FDA Calendar: PDUFA Dates & Decision History
- Apnimed, Inc. (APMD) FDA Catalysts: AD109
- Aquestive Therapeutics, Inc. (AQST) FDA Catalysts: Anaphylm
- Ardelyx, Inc. (ARDX) FDA Catalysts: Tenapanor
- argenx SE (ARGX) FDA Catalysts: VYVGART - (ADAPT SERON)
- Arcutis Biotherapeutics Inc. (ARQT) FDA Catalysts
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- Arvinas, Inc. (ARVN) FDA Catalysts: ARV-471
- Arrowhead Pharmaceuticals, Inc. (ARWR) FDA Catalysts
- Ascendis Pharma A/S (ASND) FDA Catalysts: TransCon CNP
- AtaiBeckley Inc. (ATAI) FDA Catalysts: VLS-01 readout
- Atossa Therapeutics, Inc. (ATOS) FDA Catalysts: Z-Endoxifen
- Atara Biotherapeutics, Inc. (ATRA) FDA Catalysts
- Aura Biosciences, Inc. (AURA) FDA Catalysts
- Autolus Therapeutics plc (AUTL) FDA Catalysts
- Atea Pharmaceuticals, Inc. (AVIR) FDA Catalysts
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- Axogen, Inc. (AXGN) FDA Catalysts
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- AstraZeneca PLC (AZN) FDA Catalysts: BAXFENDY (baxdrostat)
- Bayer (BAYRY) FDA Catalysts: AMBELVIST (gadoquatrane), HYRNUO
- BridgeBio Pharma, Inc. (BBIO) FDA Catalysts: BBP-418
- BioAtla, Inc. (BCAB) FDA Catalysts
- BioCardia, Inc. (BCDA) FDA Catalysts: Autologous cell therapy
- Biocryst Pharmaceuticals INC (BCRX) FDA Catalysts
- Beam Therapeutics Inc. (BEAM) FDA Catalysts: BEAM-302
- Biofrontera Inc. (BFRI) FDA Catalysts: Ameluz
- Biohaven Ltd. (BHVN) FDA Catalysts: BHV-1300
- Biogen Inc. (BIIB) FDA Catalysts: Felzartamab, LEQEMBI IQLIK
- BioAge Labs, Inc. (BIOA) FDA Catalysts: BGE-102
- Biovie Inc. (BIVI) FDA Catalysts: NE3107
- Belite Bio, Inc (BLTE) FDA Catalysts: Tinlarebant
- Biomea Fusion, Inc. (BMEA) FDA Catalysts: BMF-650 readout
- Biomarin Pharmaceutical Inc (BMRN) FDA Catalysts
- Bristol-Myers Squibb Company (BMY) FDA Catalysts
- BioNTech SE (BNTX) FDA Catalysts
- Bolt Biotherapeutics, Inc. (BOLT) FDA Catalysts
- BeyondSpring Inc. (BYSI) FDA Catalysts: Plinabulin
- Candel Therapeutics, Inc. (CADL) FDA Catalysts
- CalciMedica, Inc. (CALC) FDA Catalysts: CM4620
- Capricor Therapeutics Inc. (CAPR) FDA Catalysts: Deramiocel
- CASI FDA Calendar: PDUFA Dates & Decision History
- C4 Therapeutics, Inc. (CCCC) FDA Catalysts: Cemsidomide
- Celcuity Inc. (CELC) FDA Catalysts: Gedatolisib
- Cerus Corp (CERS) FDA Catalysts: S-303 Treated Red Blood
- Cullinan Therapeutics, Inc. (CGEM) FDA Catalysts: CLN-081
- Cognition Therapeutics Inc (CGTX) FDA Catalysts
- Coherus Oncology, Inc. (CHRS) FDA Catalysts: CHS-1420
- Cingulate Inc. (CING) FDA Catalysts: CTx-1301
- Celldex Therapeutics, Inc. (CLDX) FDA Catalysts: Barzolvolimab
- Cellectis S.A. (CLLS) FDA Catalysts: UCART22
- Cellectar Biosciences, Inc. (CLRB) FDA Catalysts: NOV-002
- Clearmind Medicine Inc. (CMND) FDA Catalysts
- COMPASS Pathways plc (CMPS) FDA Catalysts: COMP360 psilocybin
- Compass Therapeutics, Inc. (CMPX) FDA Catalysts
- CNTA FDA Calendar: PDUFA Dates & Decision History
- Cogent Biosciences (COGT) FDA Catalysts: Bezuclastinib
- Corcept Therapeutics Inc (CORT) FDA Catalysts: Relacorilant
- Corbus Pharmaceuticals Holdings, Inc. (CRBP) FDA Catalysts
- Cardiff Oncology, Inc. (CRDF) FDA Catalysts: Onvansertib
- Curis Inc (CRIS) FDA Catalysts: NCT07271667 readout
- Crinetics Pharmaceuticals, Inc. (CRNX) FDA Catalysts
- CRISPR Therapeutics (CRSP) FDA Catalysts: Casgevy
- Csl Ltd (CSLLY) FDA Catalysts: Recombinant Single-Chain
- Castle Biosciences Inc (CSTL) FDA Catalysts: FCX-007
- Cytokinetics Inc (CYTK) FDA Catalysts: Aficamten
- Definium Therapeutics, Inc. (DFTX) FDA Catalysts
- Denali Therapeutics Inc. (DNLI) FDA Catalysts
- DSNKY FDA Calendar: PDUFA Dates & Decision History
- Dogwood Therapeutics, Inc. (DWTX) FDA Catalysts: Halneuron
- Dyne Therapeutics, Inc. (DYN) FDA Catalysts
- Emergent BioSolutions (EBS) FDA Catalysts
- Elicio Therapeutics, Inc. (ELTX) FDA Catalysts: ELI-002 7P
- Enliven Therapeutics, Inc. (ELVN) FDA Catalysts: ELVN-002
- enGene Therapeutics Inc. (ENGN) FDA Catalysts
- Enanta Pharmaceuticals Inc (ENTA) FDA Catalysts
- Equillium, Inc. (EQ) FDA Catalysts
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- Estrella Immunopharma, Inc. (ESLA) FDA Catalysts
- Eton Pharmaceuticals, Inc. (ETON) FDA Catalysts: LIBERVANT
- Evommune, Inc. (EVMN) FDA Catalysts: EVO756 readout
- Exelixis (EXEL) FDA Catalysts: Cabozantinib, Zanzalintinib
- EyePoint, Inc. (EYPT) FDA Catalysts: DURAVYU COMO and CAPRI
- Fortress Biotech, Inc. (FBIO) FDA Catalysts
- 4D Molecular Therapeutics, Inc. (FDMT) FDA Catalysts
- Faeth Therapeutics, Inc. (FTH) FDA Catalysts: SNS-101
- Gilead Sciences, Inc. (GILD) FDA Catalysts: Anito-cel
- GLAUKOS Corp (GKOS) FDA Catalysts
- GLPG FDA Calendar: PDUFA Dates & Decision History
- Genmab A/S (GMAB) FDA Catalysts
- Gossamer Bio, Inc. (GOSS) FDA Catalysts: Seralutinib
- Structure Therapeutics Inc. (GPCR) FDA Catalysts
- Grace Therapeutics Inc. (GRCE) FDA Catalysts
- Grifols SA (GRFS) FDA Catalysts: ALPHA-1 MP
- GSK plc (GSK) FDA Catalysts: Arexvy, Hibsago
- Halozyme Therapeutics Inc. (HALO) FDA Catalysts
- Cybin Inc. (HELP) FDA Catalysts: HLP003 readout
- HOTH FDA Calendar: PDUFA Dates & Decision History
- Werewolf Therapeutics, Inc. (HOWL) FDA Catalysts: WTX-330
- Harmony Biosciences Holdings, Inc. (HRMY) FDA Catalysts
- Humacyte, Inc. (HUMA) FDA Catalysts: Human Acellular Vessel
- ImmunityBio, Inc. (IBRX) FDA Catalysts: ALT-803, ANKTIVA
- IDEAYA Biosciences, Inc. (IDYA) FDA Catalysts: Darovasertib
- Illumina, Inc. (ILMN) FDA Catalysts: 18F-MFBG
- ImageneBio, Inc. (IMA) FDA Catalysts: olevaprubart
- IMMUTEP Ltd (IMMP) FDA Catalysts: eftilagimod alfa
- Immix Biopharma, Inc. (IMMX) FDA Catalysts: NXC-201 readout
- Immunome, Inc. (IMNM) FDA Catalysts: Varegacestat - desmoid
- Immunic, Inc. (IMUX) FDA Catalysts: IMU-838 tablets
- Immunovant, Inc. (IMVT) FDA Catalysts: IMVT-1402
- Inhibrx Biosciences, Inc. (INBX) FDA Catalysts: INBRX-106
- Incyte Corp (INCY) FDA Catalysts: Atebrioz
- Indaptus Therapeutics, Inc. (INDP) FDA Catalysts: Decoy20
- Indivior Pharmaceuticals, Inc. (INDV) FDA Catalysts
- Inovio Pharmaceuticals (INO) FDA Catalysts: VGX-3100, VOCERYQ
- INSMED Inc (INSM) FDA Catalysts: ARIKAYCE
- INTE FDA Calendar: PDUFA Dates & Decision History
- Intensity Therapeutics, Inc. (INTS) FDA Catalysts: INT230-6
- Innoviva, Inc. (INVA) FDA Catalysts
- I-ON Digital Corp. (IONI) FDA Catalysts
- Ionis Pharmaceuticals Inc. (IONS) FDA Catalysts: Donidalorsen
- Iovance Biotherapeutics, Inc. (IOVA) FDA Catalysts: Lifileucel
- Innate Pharma SA (IPHA) FDA Catalysts: Monalizumab
- Century Therapeutics, Inc. (IPSC) FDA Catalysts
- IPSEY FDA Calendar: PDUFA Dates & Decision History
- Opus Genetics, Inc. (IRD) FDA Catalysts
- Disc Medicine, Inc. (IRON) FDA Catalysts
- Ironwood Pharmaceuticals Inc. (IRWD) FDA Catalysts
- Inventiva S.A. (IVA) FDA Catalysts: IVA337
- Inventiva S.A. (IVEVF) FDA Catalysts
- Invivyd, Inc. (IVVD) FDA Catalysts: VYD2311
- Incannex Healthcare Inc. (IXHL) FDA Catalysts
- Jazz Pharmaceuticals plc (JAZZ) FDA Catalysts: CPX-351
- Johnson & Johnson (JNJ) FDA Catalysts: ICOTYDE (icotrokinra)
- Jasper Therapeutics, Inc. (JSPR) FDA Catalysts: Briquilimab
- KALV FDA Calendar: PDUFA Dates & Decision History
- Kalaris Therapeutics, Inc. (KLRS) FDA Catalysts: TH103 readout
- Kodiak Sciences Inc. (KOD) FDA Catalysts: KSI-501 readout
- Karyopharm Therapeutics Inc. (KPTI) FDA Catalysts: Selinexor
- Korro Bio, Inc. (KRRO) FDA Catalysts
- Kura Oncology, Inc. (KURA) FDA Catalysts
- Kymera Therapeutics, Inc. (KYMR) FDA Catalysts: KT-621
- Kyntra Bio, Inc. (KYNB) FDA Catalysts: FG-3246 readout
- Kyverna Therapeutics, Inc. (KYTX) FDA Catalysts: KYV-101
- Kazia Therapeutics LTD (KZIA) FDA Catalysts
- Legend Biotech Corp (LEGN) FDA Catalysts: LCAR-B38M CAR-T Cell
- LENZ Therapeutics, Inc. (LENZ) FDA Catalysts
- Lexaria Bioscience Corp. (LEXX) FDA Catalysts
- Ligand Pharmaceuticals Incorporated (LGND) FDA Catalysts
- Eli Lilly and Company (LLY) FDA Catalysts
- Lantheus Holdings Inc. (LNTH) FDA Catalysts: LNTH-2501
- LeonaBio, Inc. (LONA) FDA Catalysts: ATH-1105 readout
- Liquidia Corp (LQDA) FDA Catalysts
- Lisata Therapeutics, Inc. (LSTA) FDA Catalysts
- Lantern Pharma Inc. (LTRN) FDA Catalysts: Tavocept
- Lexeo Therapeutics, Inc. (LXEO) FDA Catalysts: LX1001
- Lexicon Pharmaceuticals, Inc. (LXRX) FDA Catalysts
- Lyell Immunopharma, Inc. (LYEL) FDA Catalysts
- MAIA Biotechnology, Inc. (MAIA) FDA Catalysts
- Veradermics, Inc (MANE) FDA Catalysts: VDPHL01
- Moleculin Biotech, Inc. (MBRX) FDA Catalysts
- MBX Biosciences, Inc. (MBX) FDA Catalysts: MBX 2109
- Madrigal Pharmaceuticals, Inc. (MDGL) FDA Catalysts
- Mesoblast Ltd (MESO) FDA Catalysts: Rexlemestrocel-L
- MacroGenics Inc. (MGNX) FDA Catalysts
- Mirum Pharmaceuticals, Inc. (MIRM) FDA Catalysts
- Milestone Pharmaceuticals Inc. (MIST) FDA Catalysts
- Merck KGaA (EMD Serono) (MKKGY) FDA Catalysts: Pimjetmi
- MoonLake Immunotherapeutics (MLTX) FDA Catalysts: Sonelokimab
- Mineralys Therapeutics, Inc. (MLYS) FDA Catalysts
- MannKind Corporation (MNKD) FDA Catalysts: Afrezza
- Medicinova Inc (MNOV) FDA Catalysts: MN-166
- MapLight Therapeutics, Inc. (MPLT) FDA Catalysts
- Merck & Co., Inc. (MRK) FDA Catalysts: CAPVAXIVE, ENFLONSIA
- Marker Therapeutics, Inc. (MRKR) FDA Catalysts
- Moderna, Inc. (MRNA) FDA Catalysts: MFLUSIVA, MFLUSIVA
- MetaVia Inc. (MTVA) FDA Catalysts: DA-1726 readout
- Myriad Genetics Inc (MYGN) FDA Catalysts: Niraparib
- Nanobiotix S.A. (NBTX) FDA Catalysts: NBTXR3
- Neumora Therapeutics, Inc. (NMRA) FDA Catalysts
- Nurix Therapeutics, Inc. (NRIX) FDA Catalysts
- Intellia Therapeutics, Inc. (NTLA) FDA Catalysts
- Nuvation Bio Inc. (NUVB) FDA Catalysts: IBTROZI
- Nuvalent Inc. (NUVL) FDA Catalysts: JIDEYTRO (zidesamtinib)
- Novavax INC (NVAX) FDA Catalysts
- NovoCure Limited (NVCR) FDA Catalysts: Optune Mya
- Novo Nordisk A/S (NVO) FDA Catalysts: Awiqli, CagriSema
- Novartis Ag (NVS) FDA Catalysts: COSENTYX (secukinumab)
- Ocugen, Inc. (OCGN) FDA Catalysts: OCU400 readout
- Ocular Therapeutix, Inc (OCUL) FDA Catalysts: HELIOS-3 readout
- Organon & Co. (OGN) FDA Catalysts: 150μg CFA
- Olema Pharmaceuticals, Inc. (OLMA) FDA Catalysts: Palazestrant
- Omeros Corp (OMER) FDA Catalysts
- BeOne Medicines Ltd. (ONC) FDA Catalysts
- Oncolytics Biotech Inc (ONCY) FDA Catalysts: REOLYSIN
- Outlook Therapeutics, Inc. (OTLK) FDA Catalysts
- Otsuka Pharmaceutical (OTSKY) FDA Catalysts: Centanafadine
- Puma Biotechnology, Inc. (PBYI) FDA Catalysts: neratinib
- Vaxcyte, Inc. (PCVX) FDA Catalysts: OPUS-1 readout
- Pfizer Inc. (PFE) FDA Catalysts: BRAFTOVI (encorafenib)
- Precigen, Inc. (PGEN) FDA Catalysts
- Pharming Group N.V. (PHAR) FDA Catalysts: Joenja
- Phathom Pharmaceuticals, Inc. (PHAT) FDA Catalysts: Vonoprazan
- Phio Pharmaceuticals Corp. (PHIO) FDA Catalysts
- PHRRF FDA Calendar: PDUFA Dates & Decision History
- Pharvaris N.V. (PHVS) FDA Catalysts: Deucrictibant IR
- ProMIS Neurosciences Inc. (PMN) FDA Catalysts: PMN310 readout
- Purple Biotech Ltd. (PPBT) FDA Catalysts: IM1305 readout
- Praxis Precision Medicines Inc. (PRAX) FDA Catalysts
- Prokidney Corp. (PROK) FDA Catalysts: REGEN-006 readout
- PRTC FDA Calendar: PDUFA Dates & Decision History
- Ptc Therapeutics, Inc. (PTCT) FDA Catalysts: PTC923
- Protagonist Therapeutics Inc. (PTGX) FDA Catalysts
- Palvella Therapeutics, Inc. (PVLA) FDA Catalysts
- PolyPid Ltd. (PYPD) FDA Catalysts: D-PLEX100 - prevention
- Quince Therapeutics, Inc. (QNCX) FDA Catalysts
- uniQure N.V. (QURE) FDA Catalysts: Ifezuntirgene inilparvovec
- Rapport Therapeutics, Inc. (RAPP) FDA Catalysts
- Ultragenyx Pharmaceutical Inc. (RARE) FDA Catalysts
- Rocket Pharmaceuticals Inc. (RCKT) FDA Catalysts: KRESLADI
- Arcus Biosciences, Inc. (RCUS) FDA Catalysts: Zimberelimab
- Regeneron Pharmaceuticals Inc. (REGN) FDA Catalysts
- Replimune Group, Inc. (REPL) FDA Catalysts: RP1, RP1
- REGENXBIO Inc. (RGNX) FDA Catalysts: RGX-314 readout
- Roche Holding AG (RHHBY) FDA Catalysts
- Cartesian Therapeutics, Inc. (RNAC) FDA Catalysts: Decartes-08
- Transcode Therapeutics, Inc. (RNAZ) FDA Catalysts
- Roivant Sciences Ltd. (ROIV) FDA Catalysts: Brepocitinib
- Revolution Medicines, Inc. (RVMD) FDA Catalysts
- Rhythm Pharmaceuticals, Inc. (RYTM) FDA Catalysts
- Scynexis Inc (SCYX) FDA Catalysts: SCY-247 readout
- Siga Technologies Inc (SIGA) FDA Catalysts
- Sionna Therapeutics, Inc. (SION) FDA Catalysts: SION-719
- Skye Bioscience, Inc. (SKYE) FDA Catalysts: nimacimab readout
- Solid Biosciences Inc. (SLDB) FDA Catalysts: SGT-003
- Sol-Gel Technologies Ltd. (SLGL) FDA Catalysts
- Silence Therapeutics plc (SLN) FDA Catalysts: SLN124
- SLNO FDA Calendar: PDUFA Dates & Decision History
- SELLAS Life Sciences Group, Inc. (SLS) FDA Catalysts
- Summit Therapeutics Inc. (SMMT) FDA Catalysts: Ivonescimab
- Syndax Pharmaceuticals Inc (SNDX) FDA Catalysts
- Soligenix, Inc. (SNGX) FDA Catalysts: Hypericin
- SNSE FDA Calendar: PDUFA Dates & Decision History
- Sanofi (SNY) FDA Catalysts: DUPIXENT (dupilumab)
- Spero Therapeutics Inc. (SPRO) FDA Catalysts: Tebipenem HBr
- ARS Pharmaceuticals (SPRY) FDA Catalysts
- Sarepta Therapeutics, Inc. (SRPT) FDA Catalysts: Eteplirsen
- Scholar Rock Holding Corporation (SRRK) FDA Catalysts
- Shattuck Labs, Inc. (STTK) FDA Catalysts: SL-846 readout
- Supernus Pharmaceuticals, Inc. (SUPN) FDA Catalysts: BIS-001
- Savara (SVRA) FDA Catalysts: MOLBREEVI, Molgramostim
- SWTX FDA Calendar: PDUFA Dates & Decision History
- Spyre Therapeutics, Inc. (SYRE) FDA Catalysts: SPY001 readout
- Takeda Pharmaceutical Co Ltd (TAK) FDA Catalysts
- Protara Therapeutics, Inc. (TARA) FDA Catalysts
- Tarsus Pharmaceuticals, Inc. (TARS) FDA Catalysts: TP-03
- Tectonic Therapeutic, Inc. (TECX) FDA Catalysts
- Tenax Therapeutics, Inc. (TENX) FDA Catalysts: TNX-103
- Teva Pharmaceutical Industries (TEVA) FDA Catalysts
- TriSalus Life Sciences, Inc. (TLSI) FDA Catalysts: SD-101
- Telix Pharmaceuticals Limited (TLX) FDA Catalysts
- Thermo Fisher Scientific Inc. (TMO) FDA Catalysts: MK-7240
- Tango Therapeutics, Inc. (TNGX) FDA Catalysts: S095035
- Tonix Pharmaceuticals Holding Corp. (TNXP) FDA Catalysts
- Traws Pharma, Inc. (TRAW) FDA Catalysts: rigosertib
- First Tracks Biotherapeutics, Inc. (TRAX) FDA Catalysts
- Trevi Therapeutics, Inc. (TRVI) FDA Catalysts
- TRex Bio, Inc. (TRXB) FDA Catalysts: TRB-061
- Taysha Gene Therapies, Inc. (TSHA) FDA Catalysts: TSHA-101
- Turn Therapeutics Inc. (TTRX) FDA Catalysts: GX-03 readout
- TURN FDA Calendar: PDUFA Dates & Decision History
- Travere Therapeutics Inc. (TVTX) FDA Catalysts
- Tyra Biosciences, Inc. (TYRA) FDA Catalysts
- Unicycive Therapeutics Inc. (UNCY) FDA Catalysts
- Upstream Bio, Inc. (UPB) FDA Catalysts: Verekitug
- UroGen Pharma Ltd. (URGN) FDA Catalysts: UGN-103
- Vera Therapeutics Inc. (VERA) FDA Catalysts: Atacicept
- Vir Biotechnology, Inc. (VIR) FDA Catalysts: Bulevirtide
- Viking Therapeutics, Inc. (VKTX) FDA Catalysts
- Vanda Pharmaceuticals Inc. (VNDA) FDA Catalysts
- Viridian Therapeutics Inc. (VRDN) FDA Catalysts
- Vertex Pharmaceuticals (VRTX) FDA Catalysts: Casgevy
- Verastem, Inc. (VSTM) FDA Catalysts: AVMAPKI FAKZYNJA CO-PACK
- Vistagen Therapeutics, Inc. (VTGN) FDA Catalysts
- Viatris Inc. (VTRS) FDA Catalysts: Cenerimod, MR-100A-01
- Vaxart, Inc. (VXRT) FDA Catalysts: VXA-COV2-3.3
- Voyager Therapeutics, Inc. (VYGR) FDA Catalysts: VY7523
- Whitehawk Therapeutics, Inc. (WHWK) FDA Catalysts
- Wave Life Sciences, Inc. (WVE) FDA Catalysts: WVE-210201
- Xenon Pharmaceuticals Inc. (XENE) FDA Catalysts
- Xeris Biopharma Holdings, Inc. (XERS) FDA Catalysts
- Xencor Inc (XNCR) FDA Catalysts: XMAB20717
- XORTX Therapeutics Inc. (XRTX) FDA Catalysts
- Zenas BioPharma, Inc. (ZBIO) FDA Catalysts
- Zai Lab Ltd (ZLAB) FDA Catalysts
- Zura Bio Ltd (ZURA) FDA Catalysts: Tibulizumab
- Zymeworks Inc. (ZYME) FDA Catalysts: Ziihera