Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of ...

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

Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...

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

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...

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 ...

Shares of Biogen Inc. (NASDAQ:BIIB – Get Free Report) have earned a consensus rating of “Hold” from the twenty-eight ratings firms that are covering the company, MarketBeat.com reports. Sixteen ...

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

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.

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 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 ...