PDUFA Dates: April 2026

5 FDA target action dates in April 2026. Each PDUFA date is the FDA's deadline to complete review of a drug application.

Mix: 1 sBLA, 1 BLA (Class II resubmission), 1 NDA, 1 sNDA, 1 unspecified. Therapeutic areas: cns, infectious disease, oncology, rare disease. 3 Priority Review, 2 Breakthrough.

← March 2026 Full Calendar May 2026 →

Biogen Inc. BIIB APPROVED

nusinersen (high dose)

Spinal muscular atrophy Rare Disease

sBLA Orphan DrugFast TrackPriority Review

Apr 3, 2026

Details →

Denali Therapeutics Inc. DNLI APPROVED

Filed 0

Apr 5, 2026

Details →

Replimune Group, Inc. REPL CRL

RP1 (vusolimogene oderparepvec) + nivolumab

Advanced melanoma (progressed on anti-PD-1 containing regimen) Oncology

BLA (Class II resubmission) BreakthroughPriority Review

Apr 10, 2026

Details →

Merck & Co., Inc. MRK APPROVED

Doravirine/Islatravir (DOR/ISL)

Virologically suppressed HIV-1 infection (two-drug oral regimen) Infectious Disease

NDA

Apr 28, 2026

Details →

Axsome Therapeutics, Inc. AXSM APPROVED

AXS-05 (dextromethorphan-bupropion)

Agitation associated with Alzheimer's disease CNS

sNDA BreakthroughPriority Review

Apr 30, 2026

Details →

← March 2026 May 2026 →

All PDUFA Months

March 2026 (2) April 2026 (5) May 2026 (6) June 2026 (16) July 2026 (8) August 2026 (16) September 2026 (14) October 2026 (9) November 2026 (13) December 2026 (9) January 2027 (4) February 2027 (1) April 2027 (1) May 2027 (1)