PDUFA Dates: February 2026
4 FDA target action dates in February 2026. Each PDUFA date is the FDA's deadline to complete review of a drug application.
Mix: 1 BLA, 1 NDA, 2 unspecified. Therapeutic areas: metabolic. 1 Priority Review.
Climb Bio, Inc. CLYM
0 Feb 1, 2026
167 days ago
REGENXBIO Inc. RGNX CRL
RGX-121 (clemidsogene lanparvovec) Mucopolysaccharidosis Type II (Hunter syndrome)
BLA Priority ReviewOrphan Drug
Feb 8, 2026
160 days ago
Eton Pharmaceuticals, Inc. ETON APPROVED
ET-600/DESMODA (desmopressin oral solution) Central diabetes insipidus (AVP deficiency) in pediatric patients Metabolic
NDA
Feb 25, 2026
143 days ago
Ascendis Pharma A/S ASND
0 Feb 28, 2026
140 days ago