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

Fifth Third Bancorp reduced its stake in Biogen Inc. (NASDAQ:BIIB – Free Report) by 3.4% in the fourth quarter, ...

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

BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.

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

Exchange Traded Concepts LLC lifted its stake in shares of Biogen Inc. (NASDAQ:BIIB – Free Report) by 37.5% during the 4th ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...

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 ...

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 ...

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 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 ...