Merck withdraws Marketing Authorisation Application for ridaforolimus in Europe Merck has formally notified the European Medicines Agency of Merck's decision to withdraw the Marketing Authorisation Application for ridaforolimus. Merck said that the withdrawal of ridaforolimus was based on the provisional view of the Committee for Medicinal Products for Human Use that the data available to date and provided in the Marketing Authorisation Application were not sufficient to permit licensure of ridaforolimus in the European Union for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor. Although the application for these uses was withdrawn, Merck is studying ridaforolimus in combination with other drugs in other tumor types.
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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.