Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response.
Merck today announced that the U.S. FDA has accepted the biologics license application and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola Zaire virus.
The Prescription Drug User Fee Act, or target action date, is set for 14 March 2020. In July 2016, the FDA granted breakthrough therapy designation to V920.
