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 ...

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 ...

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 ...

The high-dose Spinraza is Biogen's answer to competitors such as Novartis' gene therapy Zolgensma. Xifaxan is one of 15 drugs up for the second cycle of Medicare price negotiations under the ...

Stock analysts at Wedbush lowered their Q4 2024 earnings estimates for Biogen in a research report issued on Thursday, January 23rd. Wedbush analyst L. Chico now forecasts that the biotechnology ...

Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...

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

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 ...