Biotech giant Biogen Inc (NASDAQ:BIIB) is scheduled to report fourth-quarter earnings on 12 February. The Wall Street ...
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 ...
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 ...
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen ...
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved ...
The FDA and the European Medicines Agency accepted to review supplemental marketing applications seeking approval for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA).
The Muscular Dystrophy Association celebrates this new more accessible treatment option for people living with SMA. MDA - New ...
Market OverviewThe Orphan Drugs Market is a specialized sector within the pharmaceutical industry that focuses on the ...
Q4 2024 Earnings Call Transcript February 12, 2025 Operator: Good morning. My name is Jennifer and I will be your conference ...
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are now reviewing the supplemental New Drug Application (sNDA) for nusinersen, which includes a more rapid ...