Scholar Rock Holding has resubmitted its application for its spinal muscular atrophy treatment to the Food and Drug Administration. The biopharmaceutical company said that it has sent in a new ...

The Muscular Dystrophy Association (MDA) celebrates today’s announcement that the U.S. Food and Drug Administration (FDA) has approved a High Dose Regimen of SPINRAZA® (nusinersen) for the treatment ...

Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with ...

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

The FDA has approved a higher-dose regimen of Spinraza for spinal muscular atrophy, providing a new treatment option for patients. The regimen includes 50 milligram per 5 milliliter and 28 milligram ...

On March 30, 2026, the FDA approved a high dose regimen for Spinraza (nusinersen) for the treatment of spinal muscular atrophy.

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 ...

After a surprise rejection in September last year, the FDA has signed off on a high-dose formulation of Biogen’s spinal muscular atrophy drug Spinraza. The approval, announced Monday, will allow a ...

Panelists discuss how the current spinal muscular atrophy (SMA) treatment landscape includes 3 options: gene therapy (onasemnogene abeparvovec [Zolgensma]) for younger patients and 2 splice modifiers ...

Ashley Webb, MD, Program Director, Pediatric Neurology, at the University of Texas Health Science Center at Houston McGovern Medical School, discusses the need to make genetic therapy more accessible ...

Regina Trollmann, MD, of the Division of Pediatric Neurology, Department of Pediatrics, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany, and colleagues, did a retrospective ...