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

for a higher dose regimen of nusinersen highlights Biogen's ongoing commitment to advancing treatment options for spinal muscular atrophy (SMA). The new dosing regimen has the potential to offer ...

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...

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

Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...

Biogen has said it is to file nusinersen for spinal muscular atrophy (SMA) in infants after a phase 3 trial met primary endpoint. Biogen developed the drug in partnership with Ionis, and has ...

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...

Positive results from its Phase III STEER study mean Novartis could boost sales of its OAV101 IT drug for spinal muscular ...

Newborn screening for spinal muscular atrophy allows for earlier diagnosis ... 2 patients were treated with nusinersen at PCAs of 38.7 and 38.1 weeks, and another 2 were treated with risdiplam ...

tolerability and efficacy of OAV101 IT in patients with spinal muscular atrophy who had discontinued treatment with nusinersen or risdiplam. Novartis said it will share STEER results with the FDA ...

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 ...