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: 4 sBLAs, 1 sNDA, 1 NDA. Therapeutic areas: cns, gastrointestinal, immunology, metabolic, oncology. 1 Priority Review, 1 Breakthrough.
ARGENX SE ARGX APPROVED
VYVGART (efgartigimod alfa-fcab) acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG) Immunology
sBLA
May 10, 2026
Details → Enhertu (trastuzumab deruxtecan) - post-neoadjuvant
HER2-positive early breast cancer with residual invasive disease (DESTINY-Breast05) Oncology
sBLA BreakthroughPriority Review
May 15, 2026
Details → Enhertu (trastuzumab deruxtecan) - neoadjuvant
HER2-positive early breast cancer (neoadjuvant, DESTINY-Breast11) Oncology
sBLA
May 18, 2026
Details → LINZESS (linaclotide)
functional constipation (FC) Gastrointestinal
sNDA
May 24, 2026
Details → Afrezza (Technosphere Insulin)
Pediatric diabetes, ages 4-17 (type 1 or type 2) Metabolic
sBLA
May 29, 2026
Details → Cingulate Inc. CING CRL
CTx-1301 (dexmethylphenidate) Attention-Deficit/Hyperactivity Disorder (ADHD) CNS
NDA
May 31, 2026
Details →