Gilead's HIV Pipeline Gains Traction With Upcoming FDA Decision For HIV-1 Drug

In February, the U.S. Food and Drug Administration (FDA) accepted Gilead Sciences, Inc.’s GILD New Drug Application (NDA) submissions for lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP).What Happened: The FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025.In June 2024, Gilead Sciences shared topline results from an interim ...