Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application submissions for lenacapavir for human immunodeficiency virus (HIV) prevention. Lenacapavir was granted breakthrough therapy designation for HIV prevention by the FDA in October 2024 and will be reviewed by the FDA under priority review,

The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a prescription drug user fee act (PDUFA) target action date of

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving this drug a priority review and expects to make a decision by June 19, 2025,

The FDA has accepted Gilead Sciences’ new drug application for lenacapavir as a long-lasting injectable to prevent HIV infection and set a date of June 19 to decide on its approval, Gilead announced Tuesday.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its 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).

Preventing HIV infections could soon be as simple as two shots a year. Gilead announced on Tuesday that the Food and Drug Administration (FDA) has accepted its new drug applicatio