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 ...

CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals ...

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 ...

Spinal muscular atrophy (SMA) is a rare, genetic condition that, across all types, affects ~1,600 people in the UK.1 It can cause muscle weakness which gets worse over time, causing movement, ...

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 ...

Long-term data from DEVOTE/ONWARD studies show benefits of high dose nusinersen in people living with spinal muscular atrophy (SMA) New Phase 1b data further illustrate potential of salanersen in SMA, ...

Biogen Inc. BIIB shares are up on Monday following the FDA’s approval of a new high-dose regimen for Spinraza (nusinersen), a ...

Biogen (NASDAQ:BIIB) reported that the U.S. FDA has declined to accept its request for a supplemental marketing authorization for a higher dose of Spinraza (nusinersen), a treatment for spinal ...

Biogen Inc. (NASDAQ:BIIB) on Thursday agreed to acquire Massachusetts-based Alcyone Therapeutics for $85 million. Alcyone will also receive certain milestones payable related to the development and ...

The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA ...