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Home › Calendar › November 2026

November 2026 FDA PDUFA decisions

Updated ยทnext FDA decision on the calendar
PDUFA target dates for November 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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4 PDUFA dates
AGIO · 2026-11-01
Mitapivat (PYRUKYND) - (RISE UP)
BTAI · 2026-11-14
Sublingual film containing dexmedetomidine: Agitation
SMMT · 2026-11-14
Ivonescimab
CYTK · 2026-11-14
Aficamten - (MAPLE-HCM)
SVRA · 2026-11-22
MOLBREEVI (molgramostim inhalation) - (IMPALA-2)
BBIO · 2026-11-27
EX-99
NUVL · 2026-11-27
Neladalkib (NVL-655) - (ALKOVE-1)
BAYRY · 2026-11-30
Sevabertinib (BAY 2927088): HER2-mutant NSCLC
COGT · 2026-11-30
Bezuclastinib + sunitinib - (PEAK)
REGN · 2026-11-30
Cemdisiran + pozelimab (C5 combo) - (NIMBLE)
RHHBY · 2026-11-30
Giredestrant (lidERA)
VRTX · 2026-11-30
Povetacicept (ALPN-303)
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).

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