FDA requests technical updates for Biogen's high dose nusinersen application

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Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

September 23, 2025 4:30 PM UTC

CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Companys supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be... More