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Home › Calendar › December 2026

December 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 December 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← November 2026January 2027 →
13 PDUFA dates
VNDA · 2026-12-12
Imsidolimab
CORT · 2026-12-17
Relacorilant - (GRACE resubmission): Infectious
RHHBY · 2026-12-18
Giredestrant: ER+/HER2- metastatic breast cancer
MLYS · 2026-12-22
lorundrostat Dose 1: Hypertension
GILD · 2026-12-23
Anito-cel (anitocabtagene autoleucel): Oncology
PRAX · 2026-12-27
Relutrigine (PRAX-562) - (EMBOLD) goal date moved from Sep 27, 2026
VTRS · 2026-12-27
MR-107A-02 (fast-acting meloxicam)
COGT · 2026-12-30
CGT9486: Advanced Gastrointestinal Stromal Tumors
ABBV · Dec 2026 ✓
Approved: Tavapadon (TEMPO)
AZN · Dec 2026 ✓
Approved: Ultomiris (ravulizumab)
BAYRY · Dec 2026 ✓
Approved: KERENDIA (finerenone)
NVO · Dec 2026
CagriSema (AM833)
RHHBY · Dec 2026
Gazyva: Systemic Lupus Erythematosus
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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