Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of ...
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
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 ...
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 ...
BTIG analyst Thomas Shrader has maintained their neutral stance on BIIB stock, giving a Hold rating on January 23.Invest with Confidence: ...
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 ...
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...