Pharm Exec2d
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
Nasdaq4d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
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 ...
Managed Healthcare Executive3d
FDA and EMA Accepts Applications for New Nusinersen Regimen
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 ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
The Pharma Letter4d
FDA and EMA accept filings for higher dose of nusinersen in SMA
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
GlobalData on MSN13d
Broader population could benefit from Novartis spinal muscular atrophy treatment
Positive results from its Phase III STEER study mean Novartis could boost sales of its OAV101 IT drug for spinal muscular ...
Morningstar4d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
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 ...
Healio24d
Gene therapy slows progression of spinal muscular atrophy type 2
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 ...