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

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

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 ...

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 ...

The new approval allows for the 2000mg loading dose to be administered as an IV push rather than a 30-minute IV infusion. The prescribing information for Trogarzo ® (ibalizumab-uiyk) has been updated ...