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 ...

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 ...

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 ...

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

Sales of Biogen’s key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza are declining due to competitive pressure. Biogen has ...

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

The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European ...

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