European CHMP Opinions and MAA Updates
This is a monthly 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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Five new medicines, including what could become Europe’s first ever tumor-agnostic cancer treatment, have been recommended for approval by the European Medicines Agency.
The European Medicines Agency says that Shionogi’s novel antibiotic, Fetcroja, should be approved for use across Europe but that Lilly's migraine drug, Emgality, should not be authorized for the extended indication of episodic cluster headache.
Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.