How many FDA decisions (PDUFA dates) are in December 2026?

12 PDUFA dates fall in December 2026: 8 with a confirmed day. Updated November 6, 2026.

What is the next FDA decision in December 2026?

Zanzalintinib from Exelixis, Inc. (EXEL), PDUFA target date Dec 3, for patients with metastatic CRC who have been previously treated with fluoropyrimidine-.

What is a PDUFA date?

The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

November 2026

PDUFA Dates December 2026: 12 FDA Decisions

Updated November 6, 2026

January 2027

These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →

12 FDA decisions (PDUFA target action dates) fall in December 2026: 8 with a confirmed day. Next: Zanzalintinib (EXEL) on Dec 3. Each row shows the drug, company, indication, status and how firm the date is.

FDA decisions in December 2026
Date	Company	Drug	Indication	Event	Status	Date
Dec 3	EXEL	Zanzalintinib	patients with metastatic CRC who have been previously treated with fluoropyrimidine-	PDUFA	Pending	Confirmed · source
~December	ALVO	AVT16 (vedolizumab biosimilar)	Entyvio indication (inflammatory bowel disease)	PDUFA	Pending	AI-detected · source
Dec 12	ANAB	Quimilza	generalized pustular psoriasis (GPP)	PDUFA	Pending	Confirmed · source
~December	RDY	abatacept (biosimilar)	—	PDUFA	Pending	Estimated · source
~December	VNDA	Imsidolimab	Acne Vulgaris	PDUFA	Pending	Estimated · source
Dec 17	CORT	Relacorilant	Cushing's syndrome (hypercortisolism)	PDUFA	Pending	Confirmed · source
Dec 18	CAMX.ST	CAM2029	Gastro-enteropancreatic Neuroendocrine Tumor	PDUFA	Pending	Confirmed · source
Dec 22	MLYS	Lorundrostat	Hypertension, in combination with other antihypertensive drugs	PDUFA	Pending	Confirmed · source
~December	HCM	HMPL-523	Warm Antibody Autoimmune Hemolytic Anemia	PDUFA	Pending	AI-detected · source
Dec 27	VTRS	MR-107A-02	moderate-to-severe acute pain	PDUFA	Pending	Confirmed · source
Dec 27	PRAX	PRAX-562	SCN2A and SCN8A developmental and epileptic encephalopathies	PDUFA	Pending	Confirmed · source
Dec 30	COGT	bezuclastinib	Advanced Systemic Mastocytosis (AdvSM)	PDUFA	Pending	Confirmed · source

286

Total Catalysts

PDUFA Dates

238

Trial Results

166

Companies

Week 1Nov 30 - Dec 6(32 catalysts)

NRSN$13MNDA Filing

NDA Filing — PrimeC

Dec 1AI-detected

00%

PDUFA Dates December 2026: 12 FDA Decisions

Week 1Nov 30 - Dec 6(32 catalysts)

NDA Filing — PrimeC

Regulatory

FDA PDUFA Date zanzalintinib

Week 2Dec 7 - Dec 13(17 catalysts)

FDA PDUFA Date AVT16 (vedolizumab biosimilar) (standard review)

FDA PDUFA Date Quimilza

Week 3Dec 14 - Dec 20(110 catalysts)

FDA PDUFA Date abatacept (biosimilar) (standard)

FDA PDUFA Date imsidolimab

FDA PDUFA Date relacorilant

FDA PDUFA Date CAM2029

NDA Filing — giredestrant

Week 4Dec 21 - Dec 27(18 catalysts)

FDA PDUFA Date lorundrostat

FDA PDUFA Date Sovleplenib (priority review)

FDA PDUFA Date MR-107A-02 (fast-acting meloxicam)

FDA PDUFA Date relutrigine (PRAX-562)

Week 5Dec 28 - Jan 3(109 catalysts)

FDA PDUFA Date bezuclastinib

Regulatory — Intelligent Fingerprinting Drug Screening System

NDA Filing - etavopivat

NDA Filing — PrimeC

NDA Filing

Regulatory Decision - PIKTOR

Regulatory — obicetrapib

BLA Filing — Gazyva/Gazyvaro

NDA Filing

NDA Filing — darovasertib

Regulatory — imlifidase

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