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

Analysts at RBC Capital Markets have predicted twice-yearly lenacapavir could become a $2 billion product, and become a key component of Gilead's PrEP franchise as it tries to ward off a challenge from HIV market rival ViiV Healthcare, majority owned by GSK.

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