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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.

75PDUFA and ADCOM events tracked

Monthly view

November 2026

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

FDA regulatory calendar

November 2026

16 regulatory events
01Nov 2026
AGIOPDUFA

PYRUKYND (Mitapivat)

Sickle cell disease, Anemia

Approval decision
Event details Source
14Nov 2026
BTAIPDUFA

BXCL501

Acute agitation associated with schizophrenia & bipolar disorder

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
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21
22PDUFA · SVRA
23
24
25
26
27PDUFA · BBIOPDUFA · GSK
28PDUFA · PYPD
29
30PDUFA · COGTPDUFA · VRTX+6 more
14Nov 2026
CYTKPDUFA

Aficamten

Hypertrophic cardiomyopathies

Approval decision
Event details Source
14Nov 2026
SMMTPDUFA

Ivonescimab + chemotherapy

EGFR-mutated, advanced non-squamous NSCLC (2L+ EGFRm NSCLC)

Approval decision
Event details Source
22Nov 2026
SVRAPDUFA

MOLBREEVI (Molgramostim)

Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Approval decision
Event details Source
27Nov 2026
BBIOPDUFA

BBP-418

Limb-Girdle Muscular Dystrophy

Approval decision
Event details Source
27Nov 2026
GSKPDUFA

Neladalkib (NVL-655) (ALK Inhibitor)

ALK-Altered Non-Small Cell Lung Cancer

Approval decision
Event details Source
28Nov 2026
PYPDPDUFA

D-PLEX-100

Surgical site infection

Approval decision
Event details Source
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
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
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