Merck says BLA for V503 has been accepted for review by FDA Merck announced that the Biologics License Application for V503, its investigational 9-valent human papillomavirus vaccine, has been accepted for standard review by the U.S. Food and Drug Administration.
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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.