PDUFA Dates: April 2026
6 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, 2 unspecified. Therapeutic areas: cns, infectious disease, oncology, rare disease. 3 Priority Review, 2 Breakthrough.
Biogen Inc. BIIB APPROVED
nusinersen (high dose) Spinal muscular atrophy Rare Disease
sBLA Orphan DrugFast TrackPriority Review
Apr 3, 2026
106 days ago
Denali Therapeutics Inc. DNLI
Filed 0 Apr 5, 2026
104 days ago
Replimune Group, Inc. REPL
RP1 (vusolimogene oderparepvec) + nivolumab Advanced melanoma (progressed on anti-PD-1 containing regimen) Oncology
BLA (Class II resubmission) BreakthroughPriority Review
Apr 10, 2026
99 days ago
Theriva Biologics, Inc. TOVX
0 Apr 10, 2026
99 days ago
Merck & Co., Inc. MRK APPROVED
Doravirine/Islatravir (DOR/ISL) Virologically suppressed HIV-1 infection (two-drug oral regimen) Infectious Disease
NDA
Apr 28, 2026
81 days ago
Axsome Therapeutics, Inc. AXSM
AXS-05 (dextromethorphan-bupropion) Agitation associated with Alzheimer's disease CNS
sNDA BreakthroughPriority Review
Apr 30, 2026
79 days ago