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Home › Calendar › November 2026

November 2026 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates for November 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← October 2026December 2026 →
14 PDUFA dates
TEVA · 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)
CAPR · 2026-11-22
Deramiocel (CAP-1002) - (HOPE-3) goal date moved from Aug 22, 2026
BBIO · 2026-11-27
BBP-418 (ribitol) - (FORTIFY)
GSK · Nov 2026
Neladalkib (NVL-655) - (ALKOVE-1)
RHHBY · Nov 2026
Gazyva (obinutuzumab): primary membranous nephropathy (MAJESTY)
BAYRY · Nov 2026 ✓
Approved: Sevabertinib (BAY 2927088): HER2-mutant NSCLC
PYPD · 2026-11-28
D-PLEX100: Infectious Disease
COGT · 2026-11-30
Bezuclastinib + sunitinib - (PEAK)
REGN · Nov 2026
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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