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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, has reached a pivotal phase as regulatory agencies in the United States and ...
The American Journal of Managed Care

After FDA Approval, EMA Accepts Marketing Authorization Application for First Oral SMA Therapy

The FDA approved the drug on August 7, and on August 17, the European Medicines Agency (EMA) accepted the marketing authorization application for the spinal muscular atrophy (SMA) treatment. Spinal ...
Seeking Alpha

FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA

CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application ...
Medscape

First Oral SMA Treatment Gets EMA Panel Thumbs Up

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for risdiplam (Evrysdi), the first treatment that can be given ...