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

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 ...

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

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

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 ...

A woman with SMA type 3 became pregnant while on Spinraza treatment and gave birth to a healthy child, per a case report.

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 ...

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

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 ...

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 ...