PDUFA Dates: May 2026

5 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. Therapeutic areas: cns, gastrointestinal, metabolic, oncology. 1 Priority Review, 1 Breakthrough.

What did FDA decide in May 2026?

All 5 target dates have passed: 4 approved and 1 not approved (complete response letter).

Approved: Enhertu (trastuzumab deruxtecan) - post-neoadjuvant (AstraZeneca PLC), HER2-positive early breast cancer with residual invasive disease (DESTINY-Breast05), May 15, 2026.
Approved: Enhertu (trastuzumab deruxtecan) - neoadjuvant (AstraZeneca PLC), HER2-positive early breast cancer (neoadjuvant, DESTINY-Breast11).
Approved: LINZESS (linaclotide) (IRONWOOD PHARMACEUTICALS INC), functional constipation (FC).
Approved: Afrezza (Technosphere Insulin) (MannKind Corporation), Pediatric diabetes, ages 4-17 (type 1 or type 2).
Complete response letter: CTx-1301 (dexmethylphenidate) (Cingulate Inc.), Attention-Deficit/Hyperactivity Disorder (ADHD).