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 ...
Forex Factory

The SMA Versus The EMA: Which One Is Better?

Moving averages are technical indicators used by traders and investors to define the current price direction rather than predict the price direction. The most common types of moving averages are the ...
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 ...
Nasdaq

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.
Medscape

EMA Panel Backs Zolgensma Gene Therapy for SMA

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for onasemnogene abeparvovec (Zolgensma, ...
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 ...