How many FDA PDUFA decisions are scheduled for December 2026?

pdufa.bio currently tracks 5 FDA PDUFA decisions with dates in December 2026, each linked to a primary source. The list updates as new filings appear and dates shift.

What is a PDUFA date?

A PDUFA date is the FDA's goal date to decide on a drug application under the Prescription Drug User Fee Act.

Does pdufa.bio predict whether these will be approved?

No. We do not publish per-drug approval probabilities. We provide the verified facts, primary-source links, and historical base rates so you can judge for yourself.

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Home › Calendar › December 2026

December 2026 FDA PDUFA decisions

Page updated October 10, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

PDUFA target dates for December 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.

← November 2026 January 2027 →

13 PDUFA dates

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)

VTRS · 2026-12-27

MR-107A-02 (fast-acting meloxicam)

COGT · 2026-12-30

CGT9486: Advanced Gastrointestinal Stromal Tumors

ABBV · Dec 2026

Tavapadon (TEMPO)

AZN · Dec 2026

Ultomiris (ravulizumab)

BAYRY · Dec 2026

KERENDIA (finerenone)

NVO · Dec 2026

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.

ABBV AZN BAYRY COGT CORT EXEL GILD MLYS NVO PRAX RHHBY VNDA VTRS