RHHBY
Giredestrant
FDA PDUFA Target Action Date · Genentech, Inc. (Roche)
Monday, November 30, 2026
145 days away
Drug Information
- Drug Name
- Giredestrant (CT.gov)
- Application Type
- NDA
- FDA Designations
- Priority Review
- Indication
- Adjuvant treatment of ER-positive, HER2-negative stage I, II and III early breast cancer
Filing Details
- Company
- Genentech, Inc. (Roche)
- Stock Ticker
- RHHBY
- SEC CIK
- Source
- company-press-release →
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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue