Upcoming FDA Decisions
60 PDUFA decisions with a confirmed day in the next 12 months. Estimated windows are on the monthly PDUFA calendar; resolved decisions move to outcomes.
These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →
November 2026Full month calendar →
- Nov 14Ivonescimab Injection — EGFR-mutated non-squamous NSCLC after prior EGFR TKI therapySMMT
- Nov 14Sublingual film containing Dexmedetomidine — At-home acute treatment of agitation associated with bipolar disorders or schizophreniaBTAI
- Nov 14Aficamten (CK-3773274) — Obstructive hypertrophic cardiomyopathy (label update based on MAPLE-HCM)CYTK
- Nov 22Deramiocel (CAP-1002) — Duchenne muscular dystrophy (upper limb function)CAPR
- Nov 22Molgramostim — Autoimmune pulmonary alveolar proteinosisSVRA
- Nov 25Venglustat — Type 3 Gaucher diseaseSNY
- Nov 27neladalkib — non-small cell lung cancer (ALK-positive)RPRX
- Nov 27BBP-418 — Limb-girdle muscular dystrophy type 2I/R9BBIO
- Nov 27Neladalkib (NVL-655) — TKI pre-treated advanced ALK-positive NSCLCGSK
- Nov 28D-PLEX — Prevention of surgical site infections in abdominal colorectal surgeryPYPD
- Nov 30povetacicept — immunoglobulin A nephropathy (IgAN)ZLAB
- Nov 30Giredestrant — Adjuvant ER-positive, HER2-negative stage I-III breast cancerRHHBY
- Nov 30bezuclastinib — Advanced Systemic Mastocytosis (AdvSM)COGT
- Nov 30Povetacicept — IgA nephropathyVRTX
December 2026Full month calendar →
- Dec 3Zanzalintinib — patients with metastatic CRC who have been previously treated with fluoropyrimidine-EXEL
- Dec 12Quimilza — generalized pustular psoriasis (GPP)ANAB
- Dec 17Relacorilant — Cushing's syndrome (hypercortisolism)CORT
- Dec 22Lorundrostat — Hypertension, in combination with other antihypertensive drugsMLYS
- Dec 27MR-107A-02 — moderate-to-severe acute painVTRS
- Dec 27PRAX-562 — SCN2A and SCN8A developmental and epileptic encephalopathiesPRAX
- Dec 30bezuclastinib — Advanced Systemic Mastocytosis (AdvSM)COGT
January 2027Full month calendar →
- Jan 3Efgartigimod — generalized myasthenia gravisARGX
- Jan 18HBS-102 — narcolepsyHRMY
- Jan 18ET-105 — adult refractory gastroesophageal reflux disease (rGERD)ETON
- Jan 21Zeleciment Rostudirsen (DYNE-251) — DMD who are amenable to exon 51 skippingDYN
- Jan 28Arikayce™ — Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimenINSM
- Jan 29PRAX-944 — Essential tremorPRAX
February 2027Full month calendar →
- Feb 2Lenacapavir — HIV pre-exposure prophylaxis (PrEP)GILD
- Feb 4Infigratinib — children with achondroplasiaBBIO
- Feb 7AVMAPKI FAKZYNJA CO-PACK (Blister Pack)VSTM
- Feb 9Mosunetuzumab — Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL)RHHBY
- Feb 12Tinlarebant — Stargardt Disease Type 1BLTE
- Feb 23Roflumilast — Mild to moderate atopic dermatitis in infants aged 3 to 24 monthsARQT
- Feb 27CLN-081 — patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapyCGEM
- Feb 28Vosoritide Injection — Achondroplasia in children (full approval)BMRN
- Feb 28Qtorin rapamycin — microcystic lymphatic malformationsLGND
- Feb 28AD109 (Oxnimbi) — Obstructive sleep apnea (OSA)APMD
March 2027Full month calendar →
- Mar 3Cabozantinib — Solid TumorsEXEL
- Mar 10NTLA-2002 — hereditary angioedema (“HAE”)NTLA
- Mar 16Anaphylm (dibutepinephrine) sublingual film — Type I allergic reactions, including anaphylaxisAQST
- Mar 22Clesrovimab — Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV seasonMRK
- Mar 25Oxylanthanum Carbonate — Chronic Kidney Disease Requiring Chronic DialysisUNCY
- Mar 29Diazepam Buccal Film — Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11AQST
- Mar 29LIBERVANT (diazepam buccal film) — Seizure clusters / acute repetitive seizures in patients with epilepsy (label expansion to ages 6 to 11)ETON
- Mar 31Tabelecleucel (Tab-cel®) — EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD)ATRA
April 2027Full month calendar →
- Apr 1Pitolisant GR — Narcolepsy (gastro-resistant formulation)HRMY
- Apr 14Ozekibart (INBRX-109) — Unresectable or metastatic conventional chondrosarcomaINBX
- Apr 16Cannabidiol — Sturge-Weber SyndromeJAZZ
- Apr 22IDVYNSO — HIV-1 infection in certain virologically suppressed adultsMRK
- Apr 23Deucrictibant — On-demand treatment of hereditary angioedema (HAE) attacksPHVS
- Apr 23deucrictibant — on-demand treatment of hereditary angioedema attacksRPRX
- Apr 28AL102 — adults with desmoid tumorsIMNM
May 2027Full month calendar →
- May 1AMT-191 — Fabry DiseaseQURE
- May 1AXS-12 (reboxetine) — NarcolepsyAXSM
- May 8Encaleret — autosomal dominant hypocalcemia type 1 (ADH1)BBIO
- May 13mezigdomide — relapsed or refractory multiple myeloma (RRMM), in combination with carfilzomib and dexamethasone (MeziKd)BMY
- May 27Obexelimab — IgG4-RD accepted by FDA; PDUFA target action date of May 27ZBIO
- May 27tislelizumab — pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027RPRX