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

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

Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise.

Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...

Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...

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 ...

We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...

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 ...