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Merck: FDA Grants Priority Review For Investigational Ebola Vaccine

Merck (MRK) reported that the FDA has granted priority review for the company's Biologics License Application for V920, an investigational Ebola vaccine. The PDUFA, or target action date, is set for March 14, 2020.

In March 2019, the Marketing Authorization Application for V920 was accepted for review by the European Medicines Agency.

"A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives," said Paula Annunziato, vice president, Merck Research Laboratories.

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