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

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...

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.

Biogen said the FDA accepted applications for a higher dose regimen of nusinersen in SMA. Atara Biotherapeutics said the FDA placed a clinical hold on its trials for cancer cell therapies. Johnson & ...

The FDA has accepted a supplemental New Drug Application for a higher dose regimen of nusinersen (Spinraza; Biogen Inc) for spinal muscular atrophy (SMA), according to a recent announcement from ...

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

Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, has reached a pivotal phase as regulatory agencies in the United States and Europe are now ...

and Tysabri (natalizumab), as well as blockbuster spinal muscular atrophy therapy Spinraza (nusinersen). Biogen will retain its commercial rights to the biosimilars already brought to market ...