This high dose nusinersen regimen for spinal muscular atrophy includes 50mg loading doses and 28mg maintenance doses.

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

The FDA has approved a high-dose regimen of Biogen’s nusinersen (SPINRAZA) for the treatment of spinal muscular atrophy. 1 ...

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

The FDA has approved a higher-dose regimen of Spinraza for spinal muscular atrophy, providing a new treatment option for ...

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 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. | ...

In late March 2026, Biogen announced that the U.S. FDA approved a new High Dose Regimen of SPINRAZA (nusinersen) for spinal muscular atrophy, allowing faster loading with two 50 mg doses and 28 mg ...

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 ...

Ultomiris (ravulizumab-cwvz) is a brand-name drug prescribed for certain autoimmune conditions. Ultomiris is given as an intravenous (IV) infusion by a healthcare professional. The drug’s dosing ...