Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
