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  1. Home
  2. /Regulatory
  3. /Pdufa

Regulatory Event

PDUFA

Prescription Drug User Fee Act action dates and FDA review timelines for new drug and biologics applications.

Recent events
1
Catalysts
6
Companies
5

Recent events(1)

RegulatoryJune 16, 2026

FDA Extends Decision Date for AstraZeneca's Camizestrant in HR-positive Breast Cancer

The FDA has extended the PDUFA date for camizestrant to allow for additional data review related to its NDA.

Historical activity(6)

PDUFA Date

Johnson & Johnson — Caplyta

MDD approval would significantly expand Caplyta commercial footprint.

August 5, 2026 · NDA/BLA

PDUFA Date

Regeneron — Dupixent

COPD label expansion would open multi-billion TAM beyond atopic indications.

June 27, 2026 · NDA/BLA

PDUFA Date

Vertex Pharmaceuticals — Casgevy

First CRISPR-based therapy PDUFA sets precedent for gene-editing commercialization timelines.

June 20, 2026 · NDA/BLA

Topline Data

Merck — KEYTRUDA

Monitor the PDUFA date of August 17, 2026, for potential approval outcomes and subsequent market reactions.

June 17, 2026 · N/A

Topline Data

Merck — Ifinatamab

Monitor the PDUFA date of October 10, 2026, for FDA's decision and any updates on trial results or additional indications.

June 17, 2026 · N/A

Related companies

AstraZeneca →
Johnson & Johnson →
Merck →
Regeneron →
Vertex Pharmaceuticals →

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Topline Data

AstraZeneca — Regulatory Approval

Monitor the new PDUFA date and any updates on the additional data requested by the FDA.

June 16, 2026 · N/A