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Home › Calendar › December 2026

December 2026 FDA PDUFA decisions

Updated ยทnext FDA decision on the calendar
PDUFA target dates for December 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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5 PDUFA dates
EXEL · 2026-12-03
zanzalintinib
VNDA · 2026-12-12
Milsaperidone
RHHBY · 2026-12-18
Giredestrant: ER+/HER2- metastatic breast cancer
MLYS · 2026-12-22
lorundrostat Dose 1: Hypertension
PRAX · 2026-12-27
Relutrigine (PRAX-562) - (EMBOLD)
COGT · 2026-12-30
CGT9486: Advanced Gastrointestinal Stromal Tumors
ABBV · 2026-12-31
Tavapadon (TEMPO)
AZN · 2026-12-31
Ultomiris (ravulizumab)
BAYRY · 2026-12-31
KERENDIA (finerenone)
NVO · 2026-12-31
CagriSema (AM833)
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).

Companies on this page

Every company listed above, with its full catalyst history, past FDA decisions and measured run-up into each one.
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