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Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

Every FDA catalyst in one filterable view, PDUFA decisions, clinical-trial readouts, medical conferences, and FDA advisory committee meetings. Filter by ticker, event type, therapeutic area, and date.

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Next 120 catalysts: server-rendered. Sorting and filtering load with JavaScript; this table is the same data without it.
TickerDateTypeDrugArea
CYTK2026-11-14PDUFAAficamten - (MAPLE-HCM)
SMMT2026-11-14PDUFAIvonescimab
TEVA2026-11-14PDUFAIGALMI (dexmedetomidine sublingual film) - (SERENITY
APGE2026-11-15 (est.)ReadoutAPG777Immunology
ARVN2026-11-15 (est.)ReadoutARV-471Other
ATOS2026-11-15 (est.)ReadoutZ-EndoxifenOncology
BYSI2026-11-15 (est.)ReadoutPlinabulinHematology
CGEM2026-11-15 (est.)ReadoutCLN-081Other
CRDF2026-11-15 (est.)ReadoutOnvansertibOncology
ERAS2026-11-15 (est.)ReadoutNaporafenibOther
GILD2026-11-15 (est.)ReadoutSacituzumab GovitecanOther
IMUX2026-11-15 (est.)ReadoutIMU-838 tabletsCNS
NVCR2026-11-15 (est.)PDUFATTFields therapy (Optune) - brain metastases from NSOncology
ONC2026-11-15 (est.)ReadoutBGB-11417Hematology
PHAR2026-11-15 (est.)ReadoutLeniolisibOther
SLDB2026-11-15 (est.)ReadoutSGT-003Rare disease
SNY2026-11-15 (est.)ReadoutRilzabrutinibHematology
TLX2026-11-15 (est.)Readout177Lu-TLX591Other
VIR2026-11-15 (est.)ReadoutBulevirtideInfectious
CAPR2026-11-22PDUFADeramiocel (CAP-1002) - (HOPE-3)
SVRA2026-11-22PDUFAMOLBREEVI (molgramostim inhalation) - (IMPALA-2)
BBIO2026-11-27PDUFABBP-418 (ribitol) - (FORTIFY)
PYPD2026-11-28PDUFAD-PLEX100 - prevention of surgical site infectionsInfectious Disease
COGT2026-11-30PDUFABezuclastinib + sunitinib - (PEAK)
GSK2026-11-30 (est.)PDUFANeladalkib (NVL-655) - (ALKOVE-1)
REGN2026-11-30 (est.)PDUFACemdisiran (C5 RNAi) - (NIMBLE)
RHHBY2026-11-30PDUFAGiredestrant (lidERA)
RHHBY2026-11-30 (est.)PDUFAGazyva (obinutuzumab) - primary membranous nephropatNephrology
VRTX2026-11-30PDUFAPovetacicept (ALPN-303)
VNDA2026-12-12PDUFAImsidolimab
ACTU2026-12-15 (est.)ReadoutLosartanOncology
ADCT2026-12-15 (est.)ReadoutLoncastuximab TesirineOncology
AGEN2026-12-15 (est.)ReadoutBalstilimabOncology
ARVN2026-12-15 (est.)ReadoutARV-471Oncology
AVIR2026-12-15 (est.)ReadoutBemnifosbuvir-RuzasvirInfectious
BCDA2026-12-15 (est.)ReadoutAutologous cell therapyCardiovascular
BEAM2026-12-15 (est.)ReadoutBEAM-302Hematology
BIIB2026-12-15 (est.)ReadoutFelzartamabOther
BMY2026-12-15 (est.)ReadoutNivolumabOncology
CNTA2026-12-15 (est.)ReadoutcleminorextonCNS
CORT2026-12-15 (est.)ReadoutRelacorilantRare disease
CRDF2026-12-15 (est.)ReadoutOnvansertibOncology
DWTX2026-12-15 (est.)ReadoutHalneuronCNS
EXEL2026-12-15 (est.)ReadoutCabozantinibOther
GOSS2026-12-15 (est.)ReadoutSeralutinibCardiovascular
INO2026-12-15 (est.)ReadoutVGX-3100Other
INSM2026-12-15 (est.)ReadoutTreprostinil Palmitil Inhalation PowderCardiovascular
IONS2026-12-15 (est.)ReadoutDonidalorsenOther
JAZZ2026-12-15 (est.)ReadoutCPX-351Hematology
KPTI2026-12-15 (est.)ReadoutSelinexorHematology
LXEO2026-12-15 (est.)ReadoutLX1001Cardiovascular
MANE2026-12-15 (est.)ReadoutVDPHL01Dermatology
MDGL2026-12-15 (est.)ReadoutResmetiromHepatology
MNOV2026-12-15 (est.)ReadoutMN-166Metabolic
MRK2026-12-15 (est.)ReadoutPembrolizumabOncology
NVO2026-12-15 (est.)ReadoutSemaglutideOther
ONC2026-12-15 (est.)ReadoutZanubrutinibOther
PFE2026-12-15 (est.)ReadoutElranatamabHematology
RNAC2026-12-15 (est.)ReadoutDecartes-08Immunology
SMMT2026-12-15 (est.)ReadoutIvonescimabOncology
SNY2026-12-15 (est.)ReadoutRilzabrutinibNephrology
SUPN2026-12-15 (est.)ReadoutBIS-001CNS
TRAW2026-12-15 (est.)ReadoutrigosertibInfectious
VNDA2026-12-15 (est.)ReadoutVQW-765Other
CORT2026-12-17PDUFARelacorilant - (GRACE resubmission)Endocrinology / Metabolic
RHHBY2026-12-18PDUFAGiredestrant (+ everolimus)
MLYS2026-12-22PDUFAlorundrostat Dose 1
GILD2026-12-23PDUFAAnito-cel (anitocabtagene autoleucel)Oncology
PRAX2026-12-27PDUFARelutrigine (PRAX-562) - (EMBOLD)
VTRS2026-12-27PDUFAMR-107A-02 (fast-acting meloxicam)
COGT2026-12-30PDUFABezuclastinib (CGT9486) - (SUMMIT)
ALNY2026-12-31 (est.)Readoutelebsiran readoutInfectious
ATAI2026-12-31 (est.)ReadoutVLS-01 readoutCNS
BMEA2026-12-31 (est.)ReadoutBMF-650 readout
CANF2026-12-31 (est.)ReadoutClinical readout
CMPX2026-12-31 (est.)ReadoutCTX-10726 readout
CRIS2026-12-31 (est.)ReadoutNCT07271667 readoutOncology
ENTA2026-12-31 (est.)ReadoutEDP-978 readout
EWTX2026-12-31 (est.)ReadoutClinical readout
GUTS2026-12-31 (est.)ReadoutClinical readout
HELP2026-12-31 (est.)ReadoutHLP003 readout
IPSC2026-12-31 (est.)ReadoutCNTY-813 readout
IVEVF2026-12-31 (est.)Readoutlanifibranor NATiV3 Phase 3Hepatology
KYNB2026-12-31 (est.)ReadoutFG-3246 readoutOncology
LONA2026-12-31 (est.)ReadoutATH-1105 readout
MIRM2026-12-31 (est.)ReadoutAZURE-1 readoutInfectious
MTVA2026-12-31 (est.)ReadoutDA-1726 readout
NVO2026-12-31 (est.)PDUFACagriSema (AM833)
NVO2026-12-31 (est.)PDUFAMim8 (denecimig)Hematology
PCVX2026-12-31 (est.)ReadoutOPUS-1 readoutInfectious
RAPP2026-12-31 (est.)ReadoutRAP-219 readoutCNS
RGNX2026-12-31 (est.)ReadoutRGX-314 readoutOphthalmology
RHHBY2026-12-31 (est.)PDUFAGazyva (obinutuzumab) - systemic lupus erythematosusImmunology
SKYE2026-12-31 (est.)Readoutnimacimab readout
SLGL2026-12-31 (est.)ReadoutSGT-610 readoutOncology
SLS2026-12-31 (est.)ReadoutSLS009 (tambiciclib) Phase 2 AML readoutOncology
SLS2026-12-31 (est.)ReadoutREGAL Phase 3 (galinpepimut-S) topline, event-drivenOncology
SNDX2026-12-31 (est.)ReadoutSNDX-62122 readout
TRAX2026-12-31 (est.)ReadoutANB033 readoutGastroenterology
ZBIO2026-12-31 (est.)ReadoutZB021 readout
RHHBY2027-01-10PDUFAEnspryng (satralizumab) - MOGAD (METEOROID)Neurology
APLM2027-01-15 (est.)ReadoutUproleselanOncology
BMY2027-01-15 (est.)ReadoutNivolumabHematology
CADL2027-01-15 (est.)ReadoutAglatimagene BesadenovecOther
ELVN2027-01-15 (est.)ReadoutELVN-002Oncology
EXEL2027-01-15 (est.)ReadoutCabozantinibOther
GILD2027-01-15 (est.)ReadoutMK-3475Other
IDYA2027-01-15 (est.)ReadoutDarovasertibOncology
LXRX2027-01-15 (est.)ReadoutSotagliflozinCardiovascular
NUVL2027-01-15 (est.)ReadoutNeladalkibOther
RARE2027-01-15 (est.)ReadoutSetrusumabOther
REGN2027-01-15 (est.)ReadoutOdronextamabHematology
SIGA2027-01-15 (est.)ReadoutTecovirimat Oral CapsuleInfectious
DYN2027-01-21PDUFAZ-rostudirsen - Duchenne muscular dystrophy, exon 51Rare Disease
INSM2027-01-28PDUFAARIKAYCE (amikacin liposome inhalation suspension) -Infectious Disease
PRAX2027-01-29PDUFAulixacaltamide
PHAR2027-01-30PDUFAJoenja (leniolisib) lower doses - APDS, ages 4+ fromImmunology
AGIO2027-02-01PDUFAMitapivat (PYRUKYND) - (RISE UP)
GILD2027-02-02PDUFAYeztugo (lenacapavir) once-weekly oral
BBIO2027-02-04PDUFAOral infigratinib - achondroplasia in children (PROPRare Disease