BIIB
Biogen Inc.
FDA PDUFA Target Action Date
Friday, April 3, 2026
5 days away
Drug Information
- Drug Name
- nusinersen (high dose)
- Indication
- Spinal muscular atrophy
Filing Details
- Company
- Biogen Inc.
- Stock Ticker
- BIIB
- SEC CIK
- 0000875045
- Source
- SEC 8-K →
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: 2026-02-06. Report an issue