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 ...

has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses ...

Investing.com -- Shares of Ionis Pharmaceuticals (NASDAQ: IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a ...

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 ...

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

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA ... after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene ...

Novartis' programme providing free access to its spinal muscular atrophy (SMA ... to market its antisense-based therapy Spinraza (nusinersen) since 2016, while Roche got a green light for its ...

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