New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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Alexion Pharmaceuticals’ successor to its blockbuster Soliris is among the new investigational drugs being reviewed for EU marketing approval.
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.
In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.