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The approval clears Keytruda for marketing in all 28 EU member states as well as Iceland, Lichtenstein and Norway. The drug is also approved in Europe as a monotherapy for advanced melanoma in adults. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines at its Dec. 10-13 meeting for approval by the European Commission. Read More
The agency based its approval on a Phase 3 trial that showed the regimen led to patients living significantly longer than with Avastin and chemotherapy alone. Read More