Drugs we track

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

This page lists 567 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 ACCG-2671 Phase1 event AD109 (Oxnimbi)1 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)1 event Ampligen1 event AMVUTTRA (vutrisiran)1 event AN40351 event Anaphylm (dibutepinephrine)2 events ANB0331 event Andembry (garadacimab-gxii)1 event Anito-cel (anitocabtagene autoleucel)1 event ANKTIVA (N-803)2 events Annamycin1 event AP011 event APG7773 events Apitegromab2 events Apraglutide1 event AQVESME (mitapivat)1 event ARD-1011 event Arexvy1 event ARIKAYCE (amikacin liposome inhalation suspension)1 event ARV-4713 events ASCENIV (RI-002)1 event Asundexian1 event Atacicept3 events Atebrioz (zilurgisertib)2 events ATH-11051 event Atumelnant1 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 BEQALZI (Sonrotoclax)1 event bevacizumab5 events Bezuclastinib2 events BGB-114171 event BGB-31111 event BGE-102 (oral NLRP3 inhibitor)1 event BHV-13001 event Bictegravir1 event BIIB1221 event Bimatoprost ophthalmic1 event BIS-0011 event Bitopertin3 events Blenrep1 event Blujepa (gepotidacin)2 events BMF-6501 event Botensilimab1 event BRAFTOVI (encorafenib)1 event Brekiya (dihydroergotamine mesylate)1 event Brepocitinib3 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 CALQUENCE1 event Camizestrant1 event Camzyos (mavacamten)1 event Cannabidiol oral1 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 lanparvovec (RGX-121)1 event cleminorexton2 events CLN-0812 events CM46201 event CNTY-8131 event COMIRNATY LP.8.11 event COMP360 psilocybin1 event COSENTYX (secukinumab)1 event CPX-3512 events CRB-7011 event CTEXLI (chenodiol)1 event CTX-107261 event CTx-1301 (fixed dose, pediatric study)1 event Cytisinicline1 event D-PLEX1001 event DA-17261 event Daraxonrasib (RMC-6236)1 event Darovasertib2 events DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)2 events Datopotamab Deruxtecan (Dato-DXd)2 events DATROWAY (datopotamab deruxtecan-dlnk)1 event Dawnzera (donidalorsen)2 events DAYBUE STIX (trofinetide)1 event Decartes-081 event Decoy201 event Degevma (denosumab-adet)1 event DehydraTECH1 event Deramiocel (CAP-1002)2 events deucrictibant1 event Deucrictibant IR1 event Dextromethorphan-Bupropion1 event DISC-34051 event Donidalorsen3 events Dordaviprone1 event DT1201 event DTX401 (pariglasgene brecaparvovec)1 event Dupixent (dupilumab)5 events DURAVYU COMO1 event 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 ENFLONSIA (clesrovimab)1 event Enhertu (trastuzumab deruxtecan)5 events Ensifentrine1 event Enspryng (satralizumab-mwge)2 events Envudeucitinib LUMUS1 event Epioxa1 event EPKINLY (epcoritamab-bysp)2 events Etcamah (camizestrant)1 event Eteplirsen1 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 FAYUVI1 event FCX-0071 event Felzartamab2 events FG-32461 event FILSPARI (sparsentan)4 events Foundayo (orforglipron)1 event FUROSCIX ReadyFlow1 event galinpepimut-S1 event GAMMAGARD LIQUID1 event Garadacimab2 events Garetosmab1 event Gazyva (obinutuzumab)3 events Gedatolisib2 events Giredestrant (+ everolimus)2 events GOMEKLI (mirdametinib)1 event Gozellix1 event GTX-1021 event GTX-1041 event Gvoke VialDx1 event GX-031 event Halneuron1 event Hepcludex (Bulevirtide)1 event Hibsago (bepirovirsen)1 event HLP0031 event Human Acellular2 events HWK-0071 event HYMPAVZI (marstacimab)1 event Hypericin1 event HYRNUO (sevabertinib)2 events iberdomide1 event IBRANCE (palbociclib)1 event IBTROZI (taletrectinib)2 events ICOTYDE (icotrokinra)2 events IDose TR1 event IDVYNSO (doravirine/islatravir)2 events Ifezuntirgene inilparvovec (AMT-130)1 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-1061 event INLEXZO (gemcitabine intravesical system)1 event Inluriyo (imlunestrant)2 events INT230-61 event Iohexol injection1 event ION5821 event Ipratropium Bromide1 event Iptacopan2 events Iron Sucrose1 event ISEMBYLD (apitegromab-mstn)1 event 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)2 events Jemperli (dostarlimab-gxly)1 event Joenja (leniolisib)2 events JUV1 event JUVMO (tavapadon)1 event KERENDIA (finerenone)1 event KETARX (ketamine)1 event KEYTRUDA (pembrolizumab)6 events KEYTRUDA QLEX1 event KHINDIVI1 event KOMZIFTI (ziftomenib)1 event Koselugo (selumetinib)1 event KRESLADI (marnetegragene autotemcel)1 event KRRO-121 ANCHOR1 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 lanifibranor NATiV31 event LCAR-B38M CAR-T2 events Leniolisib3 events LEQEMBI (lecanemab-irmb)1 event LEQEMBI IQLIK (lecanemab-irmb)2 events LIBERVANT (diazepam)1 event Libtayo (cemiplimab-rwlc)1 event Lifileucel3 events Linerixibat1 event LINZESS (Iinaclotide)2 events Lipfendra (enlicitide decanoate)1 event Litifilimab2 events LIVMARLI (maralixibat)1 event LNTH-2501 (Gallium-68 edotreotide)1 event Loncastuximab Tesirine1 event Lonvoguran ziclumeran (lonvo-z)1 event lorundrostat1 event Losartan1 event LUMAKRAS1 event Lunsumio VELO (mosunetuzumab-axgb)2 events Lurbinectedin3 events LX10011 event Lynkuet (elinzanetant)1 event Lynozyfic (linvoseltamab-gcpt)1 event LYTENAVA (bevacizumab-vikg)3 events MAR002 Phase1 event MAVYRET2 events MBX 21091 event Mecbotamab Vedotin1 event Mezigdomide1 event MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)1 event Mim8 (denecimig)1 event 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 Mounjaro (tirzepatide)2 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 NE31071 event neffy (epinephrine nasal spray)1 event Neffy 11 event Neladalkib (NVL-655)3 events neratinib1 event NEREUS (tradipitant)1 event nimacimab1 event Niraparib1 event Nivolumab6 events NMRA-5111 event NOV-0021 event Nucala (mepolizumab)1 event NUVAXOVID2 events NUZOLVENCE (zoliflodacin)1 event NXC-2011 event Obexelimab1 event OCU4001 event Odronextamab1 event olevaprubart (IMG-007)1 event Olezarsen3 events Olumiant (baricitinib)1 event Omvoh (mirikizumab-mrkz)2 events ONAPGO (apomorphine hydrochloride)1 event Onswik (insulin efsitora alfa-gobe)1 event Onvansertib3 events Opdivo (nivolumab)3 events OPGx-BEST1 BIRD-11 event Optune Pax (Tumor Treating Fields)1 event OPUS-11 event Opzelura1 event Oral infigratinib1 event ORLADEYO (berotralstat)1 event Otarmeni (lunsotogene parvec-cwha)1 event OTC NARCAN2 events Oveporexton (TAK-861-2001)1 event Oxylanthanum Carbonate1 event Ozekibart (INBRX-109)1 event 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)1 event Paxalisib1 event paxalisib Stage1 event Pembrolizumab10 events Penpulimab1 event Phentolamine ophthalmic1 event PI-26201 event Pitolisant GR (gastro-resistant formulation)1 event Pixclara (floretyrosine F 18; TLX101-Px)1 event Plinabulin1 event Pluvicto2 events 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 TruVu (piflufolastat F 18)1 event Qfitlia (fitusiran)3 events QTORIN rapamycin1 event RAP-2191 event Rasonque (daraxonrasib)1 event Reblozyl (luspatercept)1 event Recombinant Single-Chain1 event REDEMPLO (plozasiran)1 event REGEN-0061 event Relacorilant4 events Relutrigine (PRAX-562)1 event Remibrutinib3 events REOLYSIN1 event Repatha (evolocumab)1 event Reproxalap (ADX-102)1 event Resmetirom2 events Revuforj (revumenib)1 event Rexlemestrocel-L1 event RGX1 event RGX-3141 event Rhapsido (remibrutinib)2 events rigosertib1 event Rilzabrutinib3 events RINVOQ (upadacitinib)1 event Risperidone Extended1 event Romidepsin injection1 event Romvimza (vimseltinib)1 event RP1 (vusolimogene oderparepvec)2 events Rusfertide1 event Ruxolitinib2 events Rybelsus (oral semaglutide)1 event RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj)1 event RYZUMVI (phentolamine)2 events S-303 Treated1 event S0950351 event sabirnetug1 event Sacituzumab Govitecan3 events Sacituzumab tirumotecan (sac-TMT)1 event safusidenib1 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 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 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 Tinlarebant2 events 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 TRB-061 (TNFR2 agonist)1 event TREMFYA (guselkumab)4 events trenibotulinumtoxinE (TrenibotE)1 event Treprostinil Palmitil1 event Triheptanoin2 events Trodelvy (sacituzumab govitecan-hziy)2 events Truqap1 event TRYPTYR (acoltremon ophthalmic solution)1 event TSHA-1011 event TTFields therapy (Optune)1 event TTX2 events TUDRIQEV (vusolimogene oderparepvec-wtpg)1 event Tukysa (tucatinib)1 event TX21001 event UCART221 event UGN-103 (mitomycin)1 event ulixacaltamide1 event Ultomiris (ravulizumab)1 event Upadacitinib2 events UPLIZNA2 events Uproleselan1 event UX1111 event UZEDY1 event Vadadustat2 events Vanrafia (atrasentan)2 events Varegacestat1 event VAX-31 OPUS-21 event VDPHL012 events Veligrotug (VRDN-001)1 event Venglustat1 event VEPPANU (vepdegestrant)2 events Verekitug1 event VGX-31001 event VIZZ (aceclidine ophthalmic solution)1 event VK27351 event VLS-011 event VOCERYQ (INO-3107)1 event Vonoprazan1 event VOXZOGO (vosoritide)3 events 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)2 events Weltruza (olanzapine)1 event WINREVAIR (sotatercept-csrk)2 events WTX-3301 event WVE1 event WVE-2102012 events XEN17011 event XMAB207171 event XRx1 event YARTEMLEA1 event Yescarta (axicabtagene ciloleucel)1 event Yeztugo (lenacapavir)2 events Yutiq1 event YUTREPIA (treprostinil)1 event YUVIWEL (navepegritide)1 event z-basivarsen ACHIEVE1 event Z-Endoxifen1 event Z-rostudirsen1 event Zanidatamab3 events Zanubrutinib3 events Zanzalintinib1 event ZB0211 event Zegfrovy (sunvozertinib)1 event Zepzelca (lurbinectedin)2 events ZEVASKYN (prademagene zamikeracel)1 event Zidesamtinib (NVL-520)1 event Ziihera (zanidatamab-hrii)2 events Zilganersen1 event Zimberelimab1 event Zipalertinib (CLN-081)1 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?

567 drug programs have pages as of November 5, 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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