Friday, April 3, 2026
53 days ago
approved Drug Information
- Drug Name
- nusinersen (high dose) (CT.gov)
- Application Type
- sBLA
- FDA Designations
- Orphan DrugFast TrackPriority Review
- Indication
- Spinal muscular atrophy
- Approved As
- SPINRAZA (nusinersen) high dose regimen
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-02-06. Report an issue