Biogen’s Nusinersen Data And FDA Review Put Valuation In Focus

Biogen reported positive Phase 2/3 DEVOTE study results for high dose nusinersen in spinal muscular atrophy, published in ...

Biogen Pipeline Advances In Lupus And SMA Reshape Growth Outlook

Biogen (NasdaqGS:BIIB) received Breakthrough Therapy Designation from the FDA for litifilimab in cutaneous lupus erythematosus. The company reported phase 2/3 trial results for high dose nusinersen in ...
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Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA 1 ...
Nasdaq

Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy

Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular atrophy ...
TMCnet

Nature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy

The high-dose regimen of SPINRAZA (nusinersen) is approved in the European Union and Japan. The high-dose regimen is under review with the United States Food and Drug Administration (FDA) and has a ...
Nasdaq

Biogen Inc. Reports Positive Findings from DEVOTE and NURTURE Studies on Higher Dose Regimen of Nusinersen for Spinal Muscular Atrophy

New data from Biogen shows improved motor function in SMA patients using a higher dose of nusinersen, highlighting early treatment benefits. Biogen announced new data from the DEVOTE Part C and ...
Seeking Alpha

Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

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 Company ...
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Biogen announces FDA, EMA accepted applications for higher dose of nusinersen

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated the ...