Merck's pembrolizumab under regulatory review in Europe Merck announced the European Medicines Agency has accepted for review a Marketing Authorization Application for pembrolizumab, the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission, pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.
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FDA approves Belsomra sleep drug The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.