Monday, June 15, 2026
Decision delayed
delayed Note: DELAYED — PDUFA extended before the 2026-06-15 action date; NOT approved and NOT a CRL. FDA acted 2026-05-27 (target was 2026-06-15). Source: https://www.sec.gov/Archives/edgar/data/901832/000165495426005381/a7798f.htm
Drug Information
- Drug Name
- Camizestrant (CT.gov)
- Application Type
- NDA
- Indication
- HR+/HER2- advanced breast cancer with ESR1 mutation
- Approved As
- Camizestrant
Filing Details
- Company
- AstraZeneca PLC →
- Stock Ticker
- AZN
- SEC CIK
- 0000901832
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue