New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
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Celgene, Agios Drug Enasidenib Among New Filings At EMA
Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
New EU Filings
Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.