Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.

Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company ... rapid loading dose and an increased maintenance dose compared to the currently approved SPINRAZA® treatment, which is available in ...

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). Please click here for Important Safety Information and full ...

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Biogen’s applications for a higher dose regimen of spinal muscular atrophy (SMA) treatment Spinraza ...

Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB ... compared to the approved nusinersen regimen (SPINRAZA ®). “We are pleased to announce that our applications for the higher dose regimen ...

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc.?and?full Prescribing Information?for SPINRAZA in the U.S., or visit your ...

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.

This new regimen includes a faster loading schedule and increased maintenance dose compared to the currently approved dosing of SPINRAZA. Biogen's officials expressed optimism about the potential ...