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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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Biotech Stock Intel
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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

December 2026

SunMonTueWedThuFriSat123PDUFA · EXEL456789101112PDUFA · VNDAPDUFA · ANAB1314151617PDUFA · CORT18PDUFA · RHHBY19
PDUFA ADCOMSelect a date to filter the list

FDA regulatory calendar

December 2026

20 regulatory events
03Dec 2026
EXELPDUFA

Zanzalintinib + atezolizumab

Metastatic colorectal cancer

Approval decision
Event details Source
12Dec 2026
VNDAPDUFA

Imsidolimab (IL-36 Inhibitor)

Generalized Pustular Psoriasis

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 · LLYPDUFA · NVCR+8 more
12Dec 2026
ANABPDUFA

Imsidolimab (ANB019) (anti-IL-36R)

Hidradenitis suppurativa, Generalized pustular psoriasis, EGFRi-mediated skin toxicity, Ichthyosis, Palmoplantar pustulosis, Acne

Approval decision
Event details Source
17Dec 2026
CORTPDUFA

Relacorilant

Hypercortisolism

Approval decision
Event details Source
18Dec 2026
RHHBYPDUFA

Giredestrant

ER-positive advanced breast cancer

Approval decision
Event details Source
22Dec 2026
MLYSPDUFA

Lorundrostat

Hypertension

Approval decision
Event details Source
23Dec 2026
ACLXPDUFA

Anito-cel (anitocabtagene autoleucel)(CART-ddBCMA)

Multiple myeloma

Approval decision
Event details Source
27Dec 2026
PRAXPDUFA

Relutrigine (PRAX-562)

Developmental and Epileptic Encephalopathy (DEE)

Approval decision
Event details Source
27Dec 2026
VTRSPDUFA

Meloxicam (MR-107A-02)

Moderate-to-severe acute surgical pain

Approval decision
Event details Source
30Dec 2026
COGTPDUFA

Bezuclastinib (CGT9486) (KIT exon 17 inhibitor)

Nonadvanced systemic mastocytosis (NonAdvSM)

Approval decision
Event details Source
31Dec 2026
LLYPDUFA

Pirtobrutinib

Chronic lymphocytic leukemia (CLL)

Approval decision
Event details Source
31Dec 2026
NVCRPDUFA

Stereotactic radiosurgery (SRS) w/ NovoTTF-200M

Brain metastases

Approval decision
Event details Source
Pro
Pro
Pro