Nasdaq8d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular ...
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 ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
pharmaphorum8y
Biogen to file spinal muscular atrophy drug
Biogen has said it is to file nusinersen for spinal muscular atrophy (SMA) in infants after a phase 3 trial met primary endpoint. Biogen developed the drug in partnership with Ionis, and has ...
pharmaphorum16d
NICE in talks with Biogen after rejecting SMA drug
Cost-effectiveness body NICE has rejected Biogen’s Spinraza (nusinersen) therapy for the rare genetic muscle wasting disease spinal muscular atrophy (SMA) because of its high cost – but is in ...
BioSpace8d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Managed Healthcare Executive7d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
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 ...