Drugs we track

Updated September 23, 2026·next FDA decision on the calendar

This page lists 566 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 AB-1011 event ABCL6351 event ABP 9381 event ACCG-26711 event ADCETRIS (brentuximab vedotin)1 event ADG1061 event Aficamten1 event Afrezza (Technosphere Insulin)1 event Aglatimagene Besadenovec1 event AGMB-1291 event AJOVY (fremanezumab-vfrm)1 event AKEEGA1 event AKY-11891 event AL0011 event AL001 Phase1 event Albuterol sulfate1 event ALPHA-1 MP1 event ALT-8031 event AMBELVIST (gadoquatrane)1 event Ameluz (aminolevulinic acid hydrochloride)2 events American Diabetes1 event American Epilepsy1 event American Heart1 event American Thoracic1 event Ampligen1 event AMVUTTRA (vutrisiran)1 event Anaphylm1 event ANB0331 event Andembry (garadacimab-gxii)1 event anifrolumab2 events Anito-cel (anitocabtagene autoleucel)1 event ANKTIVA (N-803)2 events Annamycin1 event AP011 event APG7773 events Apitegromab3 events Apraglutide1 event AQVESME (mitapivat)1 event ARD-1011 event Arexvy1 event ARV-4713 events ASCENIV (RI-002)1 event Asundexian1 event Atacicept3 events ATH-11051 event Atumelnant1 event Autologous1 event AUVELITY1 event Avance Nerve1 event Avexitide1 event AVLAYAH (Tividenofusp alfa)1 event AVMAPKI FAKZYNJA1 event AVT051 event avutometinib1 event Awiqli (insulin icodec-abae)1 event AXS-121 event AXS-141 event AZURE-11 event Balstilimab1 event Barzolvolimab3 events BAXFENDY (baxdrostat)1 event BBP-418 (ribitol)1 event BDC-41821 event BEAM-3021 event Bemnifosbuvir-Ruzasvir2 events Benlysta (belimumab)1 event Bepirovirsen1 event BEQALZI (Sonrotoclax)1 event bevacizumab6 events Bezuclastinib2 events BGB-114171 event BGB-31111 event BHV-13001 event Bictegravir and1 event BIIB1221 event Bimatoprost ophthalmic1 event BIS-0011 event Bitopertin3 events Bixlenvo (bictegravir/lenacapavir)1 event Blenrep1 event Blujepa (gepotidacin)2 events BMF-6501 event Botensilimab1 event BRAFTOVI (encorafenib)1 event Brekiya (dihydroergotamine mesylate)1 event Brepocitinib5 events BREZTRI AEROSPHERE1 event BRINSUPRI1 event Briquilimab2 events Bulevirtide1 event buntanetap/posiphen1 event Bysanti (milsaperidone)2 events CABOMETYX (cabozantinib)2 events Cabozantinib6 events CagriSema1 event CALQUENCE plus1 event Camizestrant1 event Camzyos (mavacamten)1 event Canalevia-CA11 event CAPLYTA (lumateperone)1 event CAPVAXIVE1 event CARDAMYST (etripamil)1 event Casgevy (exagamglogene autotemcel)2 events Cemdisiran (C5 RNAi)2 events Cemiplimab3 events Cemsidomide1 event Cenerimod1 event Centanafadine1 event CGT94861 event CHS-14201 event Clemidsogene lanparvovec1 event cleminorexton2 events CLN-0813 events CM46201 event CNTY-8131 event COMIRNATY LP.8.11 event COMP360 psilocybin1 event Corticosteroids1 event COSENTYX (secukinumab)1 event CPX-3512 events CRB-7011 event CTEXLI (chenodiol)1 event CTX-107261 event CTx-13011 event Cytisinicline2 events DA-17261 event Daraxonrasib (RMC-6236)1 event Darovasertib2 events DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)2 events Datopotamab Deruxtecan2 events DATROWAY (datopotamab deruxtecan-dlnk)1 event Dawnzera (donidalorsen)2 events DAYBUE STIX (trofinetide)1 event Decartes-081 event Decoy201 event DehydraTECH1 event Deramiocel (CAP-1002)2 events deucrictibant1 event Deucrictibant IR1 event Dextromethorphan-Bupropion1 event Digestive Disease1 event DISC-34051 event Donidalorsen3 events Dordaviprone1 event DT1201 event DTX401 (pariglasgene brecaparvovec)1 event Dupixent (dupilumab)5 events EBGLYSS (lebrikizumab-lbkz)1 event EBVALLO1 event EDP-9781 event eftilagimod alfa3 events EKTERLY (sebetralstat)1 event elebsiran1 event ELI-002 7P1 event Elranatamab1 event ELVN-0022 events EMBLAVEO (aztreonam and avibactam)1 event EMPAVELI (pegcetacoplan)1 event EMRELIS1 event Encaleret1 event Enhertu (trastuzumab deruxtecan)5 events Ensifentrine1 event Enspryng (satralizumab)1 event Epioxa1 event EPKINLY (epcoritamab-bysp)2 events Etcamah (camizestrant)1 event Eteplirsen1 event European Hematology1 event European Respiratory1 event Everolimus1 event EVO7561 event EVRYSDI (risdiplam)1 event Exdensur (depemokimab)1 event EYLEA HD (aflibercept)3 events EYP-19012 events Fabhalta (iptacopan)1 event fasedienol1 event FAYUVI2 events FCX-0071 event Felzartamab2 events FG-32461 event FILSPARI (sparsentan)4 events Foundayo (orforglipron)1 event FUROSCIX ReadyFlow2 events galinpepimut-S1 event GAMMAGARD LIQUID1 event Garadacimab2 events Garetosmab2 events Gedatolisib2 events Gedatolisib with1 event GENGLYCOS (pariglasgene brecaparvovec-opnr)1 event Giredestrant (+ everolimus)2 events GOMEKLI (mirdametinib)1 event Gozellix1 event GTX-1021 event GTX-1041 event Gvoke VialDx1 event Gwyn Lo1 event GX-031 event Halneuron1 event HELIOS-31 event Hepcludex (Bulevirtide)1 event HLP0031 event Human Acellular2 events HWK-0071 event HYMPAVZI (marstacimab)1 event Hypericin1 event HYRNUO (sevabertinib)3 events IASLC World1 event iberdomide2 events IBRANCE (palbociclib)1 event IBTROZI (taletrectinib)3 events ICOTYDE (icotrokinra)2 events IDose TR1 event IDSA/SHEA/HIVMA IDWeek1 event IDVYNSO1 event Ifinatamab deruxtecan (I-DXd)1 event IGALMI (dexmedetomidine sublingual film)1 event IHL-42X Low1 event ILUVIEN1 event IM13051 event IMAAVY1 event IMCIVREE (setmelanotide)1 event IMFINZI (durvalumab)3 events Imsidolimab1 event IMU-838 tablets1 event IMVT-14022 events INBRX-1062 events INLEXZO (gemcitabine intravesical system)1 event Inluriyo (imlunestrant)2 events INO-3107 DNA1 event INT230-61 event Iohexol injection1 event ION5821 event Ipratropium Bromide1 event Iptacopan2 events Iron Sucrose1 event ISEMBYLD (apitegromab-mstn)2 events Isosorbide Mononitrate1 event Itvisma (onasemnogene abeparvovec-brve)1 event IVA3371 event Ivonescimab8 events IZERVAY (avacincaptad pegol intravitreal solution)1 event Jakafi XR (ruxolitinib)1 event Jaypirca (pirtobrutinib)1 event JIDEYTRO (zidesamtinib)1 event Joenja (leniolisib)2 events Joint ACTRIMS-ECTRIMS1 event JUV1 event KERENDIA (finerenone)2 events KETARX (ketamine)1 event KEYTRUDA (pembrolizumab)5 events KEYTRUDA and1 event KEYTRUDA QLEX1 event KHINDIVI1 event KOMZIFTI (ziftomenib)1 event Koselugo (selumetinib)1 event KRESLADI (marnetegragene autotemcel)1 event KSI-5011 event KT-6211 event Kygevvi (doxecitine and doxribtimine)1 event KYV-1012 events KYV-101 KYSA-11 event KYV1011 event LAM-0011 event LCAR-B38M CAR-T2 events Leniolisib3 events LEQEMBI (lecanemab-irmb)1 event LEQEMBI IQLIK (lecanemab-irmb)2 events Libtayo (cemiplimab-rwlc)1 event Lifileucel plus3 events Lifyorli (relacorilant)1 event Linerixibat1 event LINZESS (Iinaclotide)2 events Lipfendra (enlicitide decanoate)1 event LISRAYA (brepocitinib)2 events Litifilimab2 events LIVMARLI (maralixibat)1 event LNTH-2501 (Gallium-68 edotreotide)2 events Loncastuximab Tesirine1 event lorundrostat1 event Losartan1 event LUMAKRAS1 event Lumvoa (veligrotug-vvze)1 event Lunsumio VELO (mosunetuzumab-axgb)1 event Lurbinectedin3 events LX10011 event Lynkuet (elinzanetant)1 event Lynozyfic (linvoseltamab-gcpt)1 event LYTENAVA (bevacizumab-vikg)4 events MAVYRET2 events MBX 21091 event Mecbotamab Vedotin1 event MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)1 event Mim8 (denecimig)1 event MIMRYLO (rusfertide)1 event MIPLYFFA (arimoclomol)3 events Mirikizumab3 events Mitapivat4 events MK-34751 event MK-62401 event MK-72401 event MK-85271 event ML-007C-MA Phase1 event MN-1662 events MNKD-2011 event MOLBREEVI (molgramostim inhalation)1 event Molgramostim2 events Monalizumab1 event MONJUVI (tafasitamab)3 events MR-100A-011 event MR-107A-02 (fast-acting meloxicam)1 event MR-141 (phentolamine ophthalmic solution 0.75%)1 event MYQORZO1 event Nalbuphine ER1 event Naporafenib1 event NBTXR31 event NCT072716671 event NE31071 event Neffy 12 events Neladalkib (NVL-655)3 events neratinib1 event NEREUS (tradipitant)1 event nimacimab1 event Niraparib1 event Nivolumab5 events NMRA-5111 event NOV-0021 event Nucala (mepolizumab)1 event NUVAXOVID2 events NUZOLVENCE (zoliflodacin)1 event NXC-2011 event ObesityWeek1 event OCU4001 event Odronextamab1 event Olezarsen4 events Omvoh (mirikizumab-mrkz)2 events ONAPGO (apomorphine hydrochloride)1 event once-daily oral1 event Onvansertib3 events Opdivo (nivolumab)2 events Opdivo in1 event Optune Pax1 event OPUS-11 event Opzelura1 event ORLADEYO (berotralstat)1 event ORZEYFUL (oveporexton)1 event Otarmeni (lunsotogene parvec-cwha)1 event OTC NARCAN1 event Oveporexton (TAK-861-2001)2 events Oxylanthanum Carbonate2 events Oziltus (denosumab-mobz)1 event PADCEV (enfortumab vedotin)3 events Palazestrant1 event Palbociclib2 events PALSONIFY (paltusotine)1 event PALYNZIQ (pegvaliase-pqpz)1 event PAPZIMEOS (zopapogene imadenovec-drba)2 events Pasatru (garetosmab-grts)1 event Paxalisib1 event Pembrolizumab9 events Penpulimab1 event Phentolamine ophthalmic1 event PI-26201 event Pixclara (floretyrosine F 18; TLX101-Px)1 event Plinabulin1 event Pluvicto1 event PMN3101 event POHERDY (pertuzumab-dpzb)1 event PONLIMSI (denosumab-adet)1 event Povetacicept (ALPN-303)1 event Povorcitinib1 event Prucalopride Tablets1 event PTC9231 event PYLARIFY TruVu1 event Qfitlia (fitusiran)3 events R-Chop1 event RAP-2191 event Rasonque (daraxonrasib)1 event Recombinant Single-Chain1 event REDEMPLO (plozasiran)1 event REGEN-0061 event Relacorilant5 events Relutrigine (PRAX-562)1 event Remibrutinib1 event REOLYSIN1 event Reproxalap (ADX-102)1 event Resmetirom2 events REVTORPYK (gedatolisib)1 event Revuforj (revumenib)1 event Rexlemestrocel-L1 event RGX1 event RGX-3141 event Rhapsido1 event rigosertib1 event Rilzabrutinib3 events RINVOQ (upadacitinib)1 event Risperidone Extended1 event Romidepsin injection1 event Romvimza (vimseltinib)1 event RP1 (vusolimogene oderparepvec)2 events Rusfertide2 events Ruxolitinib2 events Rybelsus (oral semaglutide)1 event RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj)1 event S-303 Treated1 event S0950351 event sabirnetug1 event Sacituzumab Govitecan3 events safusidenib1 event San Antonio1 event SAPHNELO (anifrolumab-fnia)1 event SCY-2471 event SD-1011 event SELARSDI (ustekinumab-aekn)2 events Selinexor4 events Semaglutide3 events SEPHIENCE1 event Seralutinib2 events Setmelanotide2 events Setrusumab1 event SGT-0031 event SGT-6101 event Shingrix (prefilled syringe)1 event SIMTRIYO (centanafadine)1 event SION-7191 event SKYRIZI (risankizumab-rzaa)1 event SKYTROFA1 event SL-8461 event SLN1241 event SLS009 (tambiciclib)1 event SNDX-621221 event SNS-1011 event Sodium oxybate1 event Sogroya (somapacitan)1 event Solnerstotug1 event Sonelokimab2 events Sotagliflozin1 event Sotyktu (deucravacitinib)1 event SPINRAZA (Nusinersen)2 events SPN-8121 event SPRAVATO (esketamine)1 event SPY0011 event Sublingual film1 event SUBLOCADE (buprenorphine extended-release)1 event SURF303 Phase1 event Susvimo (ranibizumab injection)2 events Suzetrigine1 event SYMBRAVO (meloxicam and rizatriptan)1 event Taldefgrobep Alfa1 event Tanruprubart1 event Tarlatamab1 event TAUKLARIFY (florquinitau F 18, MK-6240)1 event Tavapadon1 event Tavocept1 event Tebipenem HBr2 events Tecentriq (atezolizumab)1 event Tecovirimat Oral1 event TECVAYLI (teclistamab-cqyv)2 events Temozolomide1 event Tenapanor3 events Teriparatide injection1 event Tezepelumab3 events TEZSPIRE (tezepelumab-ekko)2 events TH1031 event Tibulizumab1 event Tinlarebant1 event Tirzepatide1 event Tislelizumab1 event TLX1011 event TNKase (tenecteplase)1 event TNX-103 (oral levosimendan)1 event Tobevibart1 event Tolebrutinib1 event Tonmya1 event Topical Roflumilast1 event TP-031 event Tradipitant2 events TransCon CNP (navepegritide)2 events TREMFYA (guselkumab)4 events TrenibotulinumtoxinE1 event Treprostinil Palmitil1 event Triheptanoin2 events Trodelvy (sacituzumab govitecan-hziy)2 events TRUQAP (capivasertib)2 events Trutakna (atacicept)1 event TRYNGOLZA (olezarsen)1 event TRYPTYR (acoltremon ophthalmic solution)1 event TSHA-1011 event TTFields therapy (Optune)1 event TTX2 events TUDRIQEV (vusolimogene oderparepvec-wtpg)2 events TX21001 event UCART221 event ulixacaltamide1 event Ultomiris (ravulizumab)1 event Upadacitinib2 events UPLIZNA2 events Uproleselan1 event Utebzi (Tebipenem HBr)2 events UX1111 event UZEDY1 event Vadadustat2 events Vanrafia (atrasentan)2 events VDPHL012 events Veligrotug (VRDN-001)2 events Venglustat1 event VEPPANU (vepdegestrant)2 events Verekitug1 event VGX-31001 event VIZZ (aceclidine ophthalmic solution)1 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 VYKAT XR (diazoxide choline)1 event VYVGART1 event VYVGART Hytrulo (efgartigimod)2 events WAKIX (pitolisant)1 event Wayrilz (rilzabrutinib)1 event Wegovy (semaglutide)1 event Wegovy HD1 event WELIREG (belzutifan)1 event WINREVAIR (sotatercept-csrk)3 events World Muscle1 event WTX-3301 event WVE1 event WVE-2102012 events XEN17011 event XMAB207171 event XRx1 event YARTEMLEA1 event YESCARTA1 event Yeztugo (lenacapavir)2 events Yutiq1 event YUTREPIA (treprostinil)1 event YUVIWEL (navepegritide)1 event Z-Endoxifen1 event Zanidatamab3 events Zanubrutinib3 events Zanvastro (zilganersen)1 event Zanzalintinib1 event ZB0211 event Zegfrovy (sunvozertinib)1 event ZENBEXUS (iberdomide)1 event Zepzelca (lurbinectedin)2 events ZEVASKYN (prademagene zamikeracel)1 event Zidesamtinib (NVL-520)2 events Ziihera (zanidatamab-hrii)2 events Zilganersen2 events Zilurgisertib (licensed to Mirum; MIRM holds the NDA)2 events Zimberelimab1 event ZORYVE (roflumilast)4 events ZUSDURI1 event ZYCUBO (copper histidinate)2 events Zynyz (retifanlimab-dlwr)3 events

Questions

How many drugs are in this index?

566 drug programs have pages as of September 23, 2026, rebuilt daily from the catalyst dataset and the decisions archive.

What is on each drug page?

The program's next FDA decision or readout date, its catalyst history with outcomes, the sponsor, and links to every source.

How current are these pages?

Rebuilt daily; a decided event moves from upcoming to history with its outcome the day it resolves.

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

About · Corrections · Methodology

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