GlobalData on MSN13d
Biogen’s higher dose Spinraza under review by US and EU regulatorsBiogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
Zacks.com on MSN12d
FDA & EMA Accept Biogen's Filings for Higher Dose SMA DrugBIIB'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.
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Spinraza generated worldwide sales of $1.15 billion for the first nine months of 2024. Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals, ...
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...
Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.
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