GlobalData on MSN7d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
pharmaphorum8d
US/EU regulators start review of Biogen's high-dose Spinraza
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
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 ...
PMLiVE2d
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 ...
Biogen Inc. (NASDAQ:BIIB) Shares Sold by Fifth Third Bancorp
Fifth Third Bancorp reduced its stake in Biogen Inc. (NASDAQ:BIIB – Free Report) by 3.4% in the fourth quarter, ...
Exchange Traded Concepts LLC Boosts Position in Biogen Inc. (NASDAQ:BIIB)
Exchange Traded Concepts LLC lifted its stake in shares of Biogen Inc. (NASDAQ:BIIB – Free Report) by 37.5% during the 4th ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...
Morningstar8d
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
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.