Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of ...
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
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 ...
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
Analysis of Biogen's stock performance in 2024, focusing on sales struggles, financial health, and valuation. Read more here.
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
Shares of Biogen Inc. (NASDAQ:BIIB – Get Free Report) have earned a consensus rating of “Hold” from the twenty-eight ratings firms that are covering the company, MarketBeat.com reports. Sixteen ...
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...