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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.
Patients in England with non-small cell lung cancer will be the first In Europe to be offered Amgen’s KRAS G12C inhibitor.