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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

October 2026

SunMonTueWedThuFriSat1234PDUFA · MRK56789PDUFA · RHHBY10PDUFA · MRK1112131415PDUFA · RHHBY1617PDUFA · VTRS18
PDUFA ADCOMSelect a date to filter the list

FDA regulatory calendar

October 2026

8 regulatory events
04Oct 2026
MRKPDUFA

WELIREG/Belzutifan (MK-6482) + LENVIMA/Lenvatinib (E7080) (HIF-2α Combo)

Advanced Clear Cell Renal Cell Carcinoma After PD-1/PD-L1 Therapy

Approval decision
Event details Source
09Oct 2026
RHHBYPDUFA

Tecentriq/Atezolizumab (PD-L1 Antibody)

Stage III dMMR Colon Cancer (Adjuvant)

Approval decision
Event details Source

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The public calendar shows the selected month. Pro adds monitoring and date-change workflows.

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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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24PDUFA · PHAR
25
26PDUFA · IONS
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30PDUFA · INO
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10Oct 2026
MRKPDUFA

Ifinatamab Deruxtecan (I-DXd)

Small cell lung cancer, Cancer

Approval decision
Event details Source
15Oct 2026
RHHBYPDUFA

Enspryng/Satralizumab (IL-6 Receptor Inhibitor)

Thyroid Eye Disease

Approval decision
Event details Source
17Oct 2026
VTRSPDUFA

MR-141 (phentolamine ophthalmic solution 0.75%)

Presbyopia

Approval decision
Event details Source
24Oct 2026
PHARPDUFA

Leniolisib

Activated Phosphoniositide 3-kinase Delta Syndrome (APDS in children 4–11) (label expansion)

Approval decision
Event details Source
26Oct 2026
IONSPDUFA

Bepirovirsen (IONIS-HBVRx)

Hepatitis B

Approval decision
Event details Source
30Oct 2026
INOPDUFA

INO-3107

Recurrent respiratory papillomatosis (RRP)

Approval decision
Event details Source
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