PDUFA Dates: May 2026
6 FDA target action dates in May 2026. Each PDUFA date is the FDA's deadline to complete review of a drug application.
Mix: 3 sBLAs, 1 sNDA, 1 NDA, 1 unspecified. Therapeutic areas: cns, gastrointestinal, immunology, metabolic, oncology.
ARGENX SE ARGX
VYVGART (efgartigimod alfa-fcab) acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG) Immunology
sBLA
May 10, 2026
69 days ago
AstraZeneca PLC AZN APPROVED
Enhertu (trastuzumab deruxtecan) - neoadjuvant HER2-positive early breast cancer (neoadjuvant, DESTINY-Breast11) Oncology
sBLA
May 18, 2026
61 days ago
IRONWOOD PHARMACEUTICALS INC IRWD
LINZESS (linaclotide) functional constipation (FC) Gastrointestinal
sNDA
May 24, 2026
55 days ago
MannKind Corporation MNKD
Afrezza (Technosphere Insulin) Pediatric diabetes, ages 4-17 (type 1 or type 2) Metabolic
sBLA
May 29, 2026
50 days ago
May 29, 2026
50 days ago
Cingulate Inc. CING
CTx-1301 (dexmethylphenidate) Attention-Deficit/Hyperactivity Disorder (ADHD) CNS
NDA
May 31, 2026
48 days ago