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Drugs we track

Updated August 8, 2026·next FDA decision on the calendar

This page lists 313 drugs with an FDA decision date or clinical readout we track, each with its full catalyst history and sourced outcomes.

177Lu-TLX5917 events 18F-MFBG2 events 4D-150 IVT2 events 6-Thio-2'-Deoxyguanosine1 event A-1011 event AASLD The1 event AB-1011 event ABCL6351 event ABP 9381 event ACCG-26711 event ACR Convergence1 event ADG1061 event Aficamten1 event Aglatimagene Besadenovec1 event AGMB-1291 event AKY-11891 event AL0012 events ALPHA-1 MP1 event ALT-8031 event Ameluz (aminolevulinic acid hydrochloride)1 event American Epilepsy1 event American Society1 event Ampligen1 event ANB0331 event anifrolumab1 event ANKTIVA (N-803)1 event Annamycin1 event AP011 event APG7773 events ARD-1011 event ARV-4713 events ASN Kidney1 event Atacicept3 events ATH-11051 event Atumelnant1 event Autologous cell1 event avutometinib1 event AXS-121 event AXS-141 event AZURE-11 event Balstilimab1 event Barzolvolimab3 events BBP-418 (ribitol)1 event BDC-41821 event BEAM-3021 event Bemnifosbuvir-Ruzasvir2 events Bepirovirsen1 event bevacizumab2 events Bezuclastinib2 events BGB-114171 event BGB-31111 event BHV-13001 event Bictegravir and1 event BIIB1221 event BIS-0011 event BMF-6501 event Botensilimab1 event Brepocitinib3 events Briquilimab2 events Bulevirtide1 event buntanetap/posiphen1 event Cabozantinib4 events CagriSema1 event Cemdisiran2 events Cemiplimab2 events Cemsidomide1 event Cenerimod1 event Centanafadine1 event CGT94861 event CHS-14201 event cleminorexton2 events CLN-0813 events CM46201 event CNTY-8131 event COMP360 psilocybin1 event Corticosteroids1 event CPX-3512 events CRB-7011 event CTX-107261 event Cytisinicline1 event DA-17261 event Darovasertib2 events Decartes-081 event Decoy201 event Deramiocel (CAP-1002)2 events deucrictibant1 event Deucrictibant IR1 event Dextromethorphan-Bupropion1 event DISC-34051 event Donidalorsen1 event DT1201 event DTX401 AAV1 event EDP-9781 event eftilagimod alfa3 events elebsiran1 event ELI-002 7P1 event Elranatamab1 event ELVN-0022 events Encaleret1 event Ensifentrine1 event Eteplirsen1 event Eur. Assoc.1 event Eur. Society1 event European Society1 event EVO7561 event EYP-19012 events fasedienol1 event FCX-0071 event Felzartamab2 events FG-32461 event FUROSCIX ReadyFlow1 event Garetosmab1 event Gedatolisib1 event Gedatolisib with1 event Giredestrant (+ everolimus)2 events GTX-1021 event GX-031 event Halneuron1 event HELIOS-31 event HLP0031 event Human Acellular2 events HWK-0071 event Hypericin1 event IASLC World1 event iberdomide1 event IBTROZI (taletrectinib)1 event IDSA/SHEA/HIVMA IDWeek1 event Ifinatamab deruxtecan (I-DXd)1 event IGALMI (dexmedetomidine sublingual film)1 event IHL-42X Low1 event IM13051 event Imsidolimab1 event IMU-838 tablets1 event IMVT-14022 events INBRX-1062 events INO-3107 DNA1 event INT230-61 event ION5821 event Iptacopan1 event IVA3371 event Ivonescimab8 events Joint ACTRIMS-ECTRIMS (MS Toronto)1 event KERENDIA (finerenone)1 event KSI-5011 event KT-6211 event KYV-1012 events KYV-101 anti-CD191 event KYV1011 event LAM-0011 event LCAR-B38M CAR-T2 events Leniolisib2 events Lifileucel plus3 events Lipfendra (enlicitide decanoate)1 event Litifilimab2 events LNTH-2501 (Gallium-68 edotreotide)1 event Loncastuximab Tesirine1 event lorundrostat1 event Losartan1 event Lurbinectedin1 event LX10011 event MBX 21091 event MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)1 event Mirikizumab1 event Mitapivat3 events MK-34751 event MK-62401 event MK-72401 event MK-85271 event ML-007C1 event MN-1662 events MNKD-2011 event MOLBREEVI (molgramostim inhalation)1 event Molgramostim1 event Monalizumab1 event MR-100A-011 event MR-1411 event Nalbuphine ER1 event Naporafenib1 event NBTXR31 event NCT072716671 event NE31071 event Neladalkib (NVL-655)3 events neratinib1 event nimacimab1 event Niraparib1 event Nivolumab3 events NMRA-5111 event NOV-0021 event NXC-2011 event OCU4001 event Odronextamab1 event Olezarsen3 events Onvansertib3 events OPUS-11 event Oveporexton (TAK-861-2001)1 event Oxylanthanum Carbonate (OLC)1 event Palazestrant1 event Palbociclib1 event Pembrolizumab4 events PI-26201 event Plinabulin1 event PMN3101 event Povetacicept (ALPN-303)1 event Povorcitinib1 event PTC9231 event R-Chop1 event RAP-2191 event Recombinant Single-Chain1 event REGEN-0061 event Relacorilant3 events Relutrigine (PRAX-562)1 event Remibrutinib1 event REOLYSIN1 event Resmetirom2 events Rexlemestrocel-L1 event RGX-3141 event rigosertib1 event Rilzabrutinib2 events RP11 event Rusfertide1 event Ruxolitinib1 event S-303 Treated1 event S0950351 event sabirnetug1 event Sacituzumab Govitecan3 events safusidenib1 event San Antonio1 event SCY-2471 event SD-1011 event Selinexor4 events Semaglutide2 events Seralutinib2 events Setmelanotide1 event Setrusumab1 event Sevabertinib1 event SGT-0031 event SGT-6101 event SION-7191 event SL-8461 event SLN1241 event SLS009 (tambiciclib)1 event SNDX-621221 event SNS-1011 event Society for1 event Sonelokimab2 events Sotagliflozin1 event SPN-8121 event SPY0011 event Sublingual film1 event SURF3031 event Taldefgrobep Alfa1 event Tanruprubart1 event Tavapadon1 event Tavocept1 event Tebipenem HBr2 events Tecovirimat Oral1 event Temozolomide1 event Tenapanor3 events Tezepelumab1 event TH1031 event Tibulizumab1 event Tinlarebant1 event Tirzepatide1 event Tislelizumab1 event TLX101-Px1 event Tobevibart1 event Topical Roflumilast1 event TP-031 event Tradipitant1 event TransCon CNP1 event Treprostinil Palmitil1 event Triheptanoin2 events Truqap1 event TSHA-1011 event TUDRIQEV (vusolimogene oderparepvec-wtpg)1 event TX21001 event UCART221 event ulixacaltamide1 event Ultomiris (ravulizumab)1 event Uproleselan1 event UX1111 event Vadadustat2 events VDPHL012 events Veligrotug (VRDN-001)1 event Venglustat1 event Verekitug1 event VGX-31001 event VK27351 event VLS-011 event Vonoprazan1 event Vosoritide1 event VQW-7651 event VSJ-1101 event VXA-COV2-3.31 event VY75231 event VYD23111 event WTX-3301 event WVE-2102012 events XEN17011 event XMAB207171 event Yeztugo (lenacapavir)1 event Yutiq1 event Z-Endoxifen1 event Zanidatamab1 event Zanubrutinib3 events Zanzalintinib1 event ZB0211 event Zidesamtinib (NVL-520)1 event Ziihera (zanidatamab-hrii)2 events Zilganersen1 event zilurgisertib2 events Zimberelimab1 event ZORYVE (roflumilast)2 events

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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