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Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
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FDA regulatory calendar

PDUFA Calendar

Track FDA action dates and advisory committee meetings by month. Each event links to its company, drug, indication and source-backed research record.

115PDUFA and ADCOM events tracked

Monthly view

December 2026

SunMonTueWedThuFriSat123PDUFA · EXEL456789101112PDUFA · ANABPDUFA · VNDA1314151617PDUFA · CORT18PDUFA · RHHBY19
PDUFA ADCOMSelect a date to filter the list

FDA regulatory calendar

December 2026

20 regulatory events
31Dec 2026
ALVOPDUFA

AVT05 (Proposed Biosimilar to Simponi® & Simponi Aria® (golimumab))

Inflammatory disease

Approval decision
Event details Source
31Dec 2026
ALVOPDUFA

Mynzepli® (AVT06, a Proposed Biosimilar to Eylea®) (aflibercept)

Eye disease

Approval decision
Event details Source
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Calendar methodology

Dates are normalized from company guidance and source records. Approximate dates may be represented by a reference date while retaining the original guidance label.

Read methodology

Updated Aug 23, 2026. Dates can change and are not investment advice.

PDUFA dates and FDA advisory meetings

Use the monthly FDA calendar to review PDUFA target dates and advisory committee meetings, then open each event for drug, company, indication and source context.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy
20
21
22PDUFA · MLYS
23PDUFA · ACLX
24
25
26
27PDUFA · PRAXPDUFA · VTRS
28
29
30PDUFA · COGT
31PDUFA · NVCRPDUFA · LLY+8 more
31Dec 2026
RHHBYPDUFA

Gazyva®/Gazyvaro® (obinutuzumab) (CD20 Antibody)

Systemic Lupus Erythematosus

Approval decision
Event details Source
31Dec 2026
INCYPDUFA

Olumiant/Baricitinib (JAK Inhibitor)

Severe Alopecia Areata In Adolescents

Approval decision
Event details Source
31Dec 2026
ABBVPDUFA

SKYRIZI/Risankizumab (N/A) (IL-23 Inhibitor)

Crohn's Disease

Approval decision
Event details Source
31Dec 2026
ONCPDUFA

TEVIMBRA/Tislelizumab + ZIIHERA/Zanidatamab (PD-1 Antibody)

First-Line HER2-Positive Gastroesophageal Adenocarcinoma

Approval decision
Event details Source
31Dec 2026
PFEPDUFA

Talzenna/Talazoparib + Xtandi/Enzalutamide (BMN 673 + MDV3100) (PARP Inhibitor)

HRR Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer

Approval decision
Event details Source
31Dec 2026
TAKPDUFA

Rusfertide (Hepcidin Mimetic)

Polycythemia Vera

Approval decision
Event details Source
Pro
Pro
Pro