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

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 ...

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 ...

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 ...

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 ...

Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational ...

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 ...

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 ...

CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA ® ...