TheraRadar
BIIB

nusinersen (high dose)

FDA PDUFA Target Action Date · Biogen Inc.

Friday, April 3, 2026
Approved
approved

Note: Approved March 30, 2026 for spinal muscular atrophy. Based on DEVOTE study. Source: https://investors.biogen.com/news-releases/news-release-details/fda-approves-new-high-dose-regimen-spinrazar-nusinersen-spinal

Drug Information

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

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 Biogen Inc.

View Biogen Inc.'s full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-02-06. Report an issue