Biogen Inc., BIIB, FDA Calendar, PDUFA Date

Company Name	Biogen Inc. BIIB
Drug Name	Nusinersen (sNDA)
Event Name	FDA decision on high-dose regimen of nusinersen for people living with spinal muscular atrophy (SMA)
Event Date	04/03/2026
Outcome Date	03/30/2026
Outcome	FDA approved high-dose SPINRAZA (nusinersen) regimen For treatment of Spinal Muscular Atrophy on 30th March 2026.
Drug Status	Biogen holds global license to develop, manufacture, and commercialize SPINRAZA (nusinersen) from Ionis Pharmaceuticals
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Market Potential
Other Approvals	SPINRAZA (nusinersen) was approved by the FDA on December 23, 2016, as the first treatment for Spinal Muscular Atrophy (SMA) in pediatric and adult patients.
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