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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
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Monthly view

November 2026

SunMonTueWedThuFriSat1PDUFA · AGIO234567891011121314PDUFA · BTAIPDUFA · CYTK+1 more151617181920
PDUFA ADCOMSelect a date to filter the list

FDA regulatory calendar

November 30, 2026

8 regulatory events
30Nov 2026
COGTPDUFA

Bezuclastinib (CGT9486) (KIT exon 17 inhibitor) + Sunitinib

Cancer, Gastrointestinal stromal tumors

Approval decision
Event details Source
30Nov 2026
VRTXPDUFA

Povetacicept

IgA Nephropathy (IgAN)

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
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22PDUFA · SVRA
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25
26
27PDUFA · BBIOPDUFA · GSK
28PDUFA · PYPD
29
30PDUFA · COGTPDUFA · VRTX+6 more
30Nov 2026
REGNPDUFA

Cemdisiran

Myasthenia gravis

Approval decision
Event details Source
30Nov 2026
RHHBYPDUFA

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

Primary Membranous Nephropathy

Approval decision
Event details Source
30Nov 2026
RHHBYPDUFA

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

Primary Membranous Nephropathy

Approval decision
Event details Source
30Nov 2026
RHHBYPDUFA

Giredestrant (Estrogen Receptor Degrader)

Early-Stage ER-Positive HER2-Negative Breast Cancer

Approval decision
Event details Source
30Nov 2026
RHHBYPDUFA

Giredestrant (GDC-9545) (Estrogen Receptor Degrader)

Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Approval decision
Event details Source
30Nov 2026
ZLABPDUFA

Povetacicept (Pove) (APRIL/BAFF Inhibitor)

Immunoglobulin A Nephropathy

Approval decision
Event details Source
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