Pharm Exec6d
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 ...
PMLiVE1d
Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...
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FDA & EMA Accept Biogen's Filings for Higher Dose SMA Drug
BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.
GlobalData on MSN7d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of spinal muscular atrophy (SMA) drug Spinraza are now under review in the US and Europe.
BioSpace7d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
ADVFN1d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted ... nusinersen regimen (SPINRAZA ®). “We are pleased to ...
Nasdaq7d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Nusinersen, marketed as SPINRAZA, targets the underlying cause of SMA and has been widely used globally. The FDA acceptance and EMA validation of the supplemental New Drug Application (sNDA ...