Tuesday, March 24, 2026
63 days ago
approved Drug Information
- Approved As
- LYNAVOY →
Filing Details
- Company
- GSK plc →
- Stock Ticker
- GSK, GLAXF
- SEC CIK
- 0001131399
- Source
- SEC 8-K Filing →
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
Explore GSK plc
View GSK plc's full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2025-06-02. Report an issue