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 ...

Biogen's treatment for neurodegenerative disorder spinal muscular atrophy (SMA) Spinraza has come under pressure in an increasingly competitive market, but the company hopes a new high-dose ...

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.

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. The ...

In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...

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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 ...

Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of its blockbuster spinal muscular atrophy (SMA) drug Spinraza. This new ...

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