FDA, SMA and Biogen
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 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.
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FDA & EMA Accept Biogen's Filings for Higher Dose SMA DrugBiogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of ...
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
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’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
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 ...
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys (Friedreich's Ataxia, Reata), Zurzuvae (postpartum depression, Sage), and ...
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
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