European 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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.
The European Medicines Agency this week recommended that five new products be granted EU marketing approval.
While the European Medicine Agency now recommends that Elzonris should be approved in the EU, Stemline Therapeutics will have to submit the results of a study based on a registry of patients with blastic plasmacytoid dendritic cell neoplasm.