The US Food and Drug Administration has approved a higher-dose version of Spinraza, a key therapy from Biogen Inc ...

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 ...

Shares of Biogen BIIB rose 2% on Monday after the company announced that the FDA approved a higher dose of its blockbuster ...

Kenneth Hobby, President of Cure SMA, said: “Nearly ten years ago, the approval of Spinraza marked a turning point in SMA ...

Spinraza is a medication used in children (including newborns) and adults to treat spinal muscular atrophy. Treatment begins with four loading doses, followed by one maintenance dose every 4 months.

After Spinraza's FDA approval nearly a decade ago, Biogen's spinal muscular atrophy (SMA) drug captured rapid momentum and delivered blockbuster-level sales in just its second year on the market. | ...

MDA’s research funding for Dr. Adrian Krainer’s research led to the groundbreaking discovery of SPINRAZA®. FDA Approves High ...

US regulators have approved a high-dose version of Biogen Inc.’s drug for a rare muscle disorder, giving the company a boost ...

Spinraza (nusinersen) is a prescription drug that treats spinal muscular atrophy (SMA) by increasing the level of a certain protein in your body. Your response to this drug may vary based on your ...

Spinraza (nusinersen) is a brand-name injection prescribed for spinal muscular atrophy in adults and children. As with other drugs, Spinraza can cause side effects, such as fever, headache, and ...

Spinraza (nusinersen) is a brand-name drug that’s prescribed for spinal muscular atrophy (SMA) in adults and children. Spinraza comes as a spinal injection that’s given by a healthcare professional ...