New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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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.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.