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2026 FDA PDUFA Calendar

Every upcoming FDA decision (PDUFA) date — drug, company, indication, run-up history, and market-cap cohort base rates. Tap any name for the full facts.
June 2026
GSK / SPRO · 2026-06-18
Tebipenem HBr (SPR994) — Complicated urinary tract infection (cUTI)…
ACHV · 2026-06-20
Cytisinicline — Smoking cessation of cigarettes
UNCY · 2026-06-29
Oxylanthanum Carbonate (OLC) — Kidney disease
ARQT · 2026-06-29
ZORYVE (roflumilast) Cream 0.3% — Plaque Psoriasis in Children Ages 2 to 5
LNTH · 2026-06-29
LNTH-2501 (Gallium-68 edotreotide) — Neuroendocrine tumors (NETs) in adult and…
HRMY · 2026-06-30
WAKIX — GI symptoms
AZN · 2026-06-30
Truqap — Dephosphorylated Phosphatase and Tensin…
NVO · 2026-06-30
Sogroya (somapacitan) — Noonan syndrome (NS)
VRDN · 2026-06-30
Veligrotug (VRDN-001) — Thyroid Eye Disease (TED)
IONS · 2026-06-30
Olezarsen — Hypertriglyceridemia
VRDN · 2026-06-30
VRDN-001 — Active Thyroid Eye Disease (TED)
GSK · 2026-06-30
Tebipenem pivoxil — cUTI
REGN · 2026-06-30
Otoferlin gene therapy (DB-OTO) — Genetic hearing loss
July 2026
VERA · 2026-07-07
Atacicept — IgA Nephropathy
CELC · 2026-07-17
Gedatolisib with Fulvestrant — HR+/HER2- advanced breast cancer
MNKD · 2026-07-26
FUROSCIX ReadyFlow Autoinjector (SCP-111) — Edema in adult patients with chronic heart…
NRXP · 2026-07-29
KETAFREE — Preservative-free intravenous ketamine…
VTRS · 2026-07-30
MR-100A-01(Low dose estrogen weekly patch… — Contraception
August 2026
MRNA · 2026-08-05
mRNA-1010 — Seasonal influenza in U.S. adults 50 years of…
LNTH · 2026-08-13
Florquinitau (MK-6240) — Alzheimer's disease
ALPMY / MRK / PFE · 2026-08-17
KEYTRUDA (pembrolizumab) plus Padcev… — Muscle-invasive bladder cancer (MIBC)
BMY · 2026-08-17
iberdomide, daratumumab, and dexamethasone… — Relapsed/refractory multiple myeloma (RRMM)
CAPR · 2026-08-22
Deramiocel (CAP-1002) — Duchenne Muscular Dystrophy (DMD)
RARE · 2026-08-23
DTX401 AAV gene therapy (pariglasgene… — Glycogen Storage Disease Type Ia (GSDIa)
BIIB · 2026-08-24
LEQEMBI IQLIK (lecanemab-irmb)(at-home… — Early Alzheimer's disease (AD) a-home…
JAZZ / ONC / ZYME · 2026-08-25
Ziihera (zanidatamab-hrii) — First-line HER2-positive gastroesophageal…
GILD · 2026-08-27
Bictegravir and Lenacapavir — HIV
REGN · 2026-08-31
Garetosmab — Fibrodysplasia Ossificans Progressiva (FOP)
September 2026
TLX · 2026-09-11
TLX101-Px — Recurrent or progressive glioma (brain cancer)
NUVL / RPRX · 2026-09-18
Zidesamtinib (NVL-520) — ROS1 Non-small cell lung cancer (NSCLC)
ABEO / RARE · 2026-09-19
UX111 — Sanfilippo syndrome type A (MPS IIIA)
MRK · 2026-09-21
WINREVAIR (sotatercept-csrk) — Pulmonary arterial hypertension (PAH, WHO*…
IONS · 2026-09-22
Zilganersen (ION373) — Alexander disease
PRAX · 2026-09-27
Relutrigine (PRAX-562) — Developmental epileptic encephalopathies…
BFRI · 2026-09-28
Ameluz (aminolevulinic acid hydrochloride)… — Basal cell carcinoma
TAK · 2026-09-30
Oveporexton (TAK-861-2001) — Narcolepsy type 1 (NT1)
PTGX · 2026-09-30
Rusfertide — Polycythemia vera
PFE / ROIV · 2026-09-30
Brepocitinib — Dermatomyositis (DM)
NVO · 2026-09-30
Mim8 — Hemophilia A
AZN · 2026-09-30
Enhertu (trastuzumab deruxtecan) — HER2-positive early breast cancer
October 2026
RHHBY · 2026-10-09
Tecentriq (atezolizumab) and Tecentriq… — Stage III colon cancer
MRK · 2026-10-10
Ifinatamab deruxtecan (DS-7300) — Extensive-stage small cell lung cancer (SCLC)
IRD / VTRS · 2026-10-17
MR-141 (phentolamine ophthalmic solution… — Presbyopia
PHAR · 2026-10-24
Leniolisib — Activated phosphoinositide 3-kinase delta…
INO · 2026-10-30
INO-3107 — HPV 6 and HPV 11-associated Recurrent…
November 2026
BTAI · 2026-11-14
IGALMI® (dexmedetomidine) — Agitation associated with bipolar I or II…
SMMT · 2026-11-14
Ivonescimab plus platinum-doublet… — EGFR-mutated, locally advanced or metastatic…
SVRA · 2026-11-22
MOLBREEVI (Molgradex) — Autoimmune pulmonary alveolar proteinosis…
BBIO · 2026-11-27
BBP-418 — Limb Girdle Muscular Dystrophy Type 2i…
NUVL · 2026-11-27
Neladalkib (NVL-655) — ALK non-small cell lung cancer (NSCLC)
VRTX · 2026-11-30
Povetacicept (ALPN-303) — Lupus nephritis, IgA nephropathy
RHHBY · 2026-11-30
Giredestrant — Early breast cancer
BAYRY · 2026-11-30
HYRNUO (sevabertinib) — HER2-mutated non-small cell lung cancer…
December 2026
EXEL · 2026-12-03
XL092 with atezolizumab — Colorectal Cancer (CRC)
ANAB / VNDA · 2026-12-12
Imsidolimab (ANB019) — Generalized pustular psoriasis
RHHBY · 2026-12-18
Giredestrant in combination with everolimus — ER-positive advanced breast cancer
MLYS · 2026-12-22
Lorundrostat — Uncontrolled hypertension (uHTN) or resistant…
VTRS · 2026-12-27
MR-107A-02 — Pain
COGT · 2026-12-30
Bezuclastinib — Non-Advanced Systemic Mastocytosis
NVO · Q4 2026 (est.)
AM833 (CagriSema) — Obesity
TAK · Q4 2026 (est.)
Rusfertide — Polycythemia vera
ABBV · Q4 2026 (est.)
Tavapadon — Early Parkinson’s disease
RHHBY · Q4 2026 (est.)
Lunsumio + Polivy — 2L+ Diffuse Large B-Cell Lymphoma (DLBCL)
ABBV · Q4 2026 (est.)
RINVOQ (upadacitinib) — Non-segmental vitiligo (NSV)
AZN / GH · Q4 2026 (est.)
Camizestrant — Hormone Receptor-Positive/Human Epidermal…
GILD / MRK · Q4 2026 (est.)
Trodelvy (sacituzumab govitecan-hziy) plus… — Inoperable (unresectable) locally advanced or…
AZN · Q4 2026 (est.)
Gefurulimab — Generalised myasthenia gravis
NVS · Q4 2026 (est.)
Pluvicto (lutetium (177Lu) vipivotide… — End-stage prostate cancer
RHHBY · Q4 2026 (est.)
Gazyva — Systemic Lupus Erythematosus
BAYRY · Q4 2026 (est.)
KERENDIA (finerenone) — Type 1 Diabetes and Chronic Kidney Disease
LLY · Q4 2026 (est.)
Tirzepatide — Cardiovascular outcomes
PFE · Q4 2026 (est.)
TUKYSA, trastuzumab, and pertuzumab — HER2+ Metastatic Breast Cancer
AZN · Q4 2026 (est.)
Ultomiris (ravulizumab) — Immunoglobulin A nephropathy