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

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