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

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

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

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 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 ...

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 ...

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.

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

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