European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir,
The Pharma Data
AUGUST 19, 2021
today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S.
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