pdufa.bio
HomeCalendar › November 2026

November 2026 FDA PDUFA decisions

PDUFA target dates for November 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← October 2026December 2026 →
4 PDUFA dates
BTAI · 2026-11-14
Sublingual film containing dexmedetomidine — Agitation
SMMT · 2026-11-14
Ivonescimab
BBIO · 2026-11-27
EX-99
BAYRY · 2026-11-30
Sevabertinib (BAY 2927088) — HER2-mutant NSCLC
Looking for an approval probability for these? We deliberately don't publish one — here's why, and what we show instead (verified history + base rates).