Lenacapavir, a twice yearly injection that prevents HIV transmission, was named the breakthrough medicine of 2024. But ...

The major backer of the lenacapavir roll-out is assuring nervous researchers that they will keep their part of funding ...

The FDA has accepted under Priority Review the NDA for lenacapavir for the prevention of HIV as pre-exposure prophylaxis.

Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...

A revolutionary advancement in HIV prevention technology stands at a critical crossroads as recent policy decisions threaten ...

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 ...

A groundbreaking injectable designed to curb the global spread of HIV is now at risk of being delayed due to Donald Trump's ...

Based on the assessment of EMA’s Committee for Medicinal Products for Human Use (CHMP) that twice-yearly lenacapavir for prevention is a product of major interest for public health and ...

Missed KHOU 11+’s live Q&A on injectable PrEP? Watch on demand as experts discuss this HIV prevention breakthrough and answer ...

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, ...

(RTTNews) - Gilead Sciences, Inc. (GILD) Monday announced that the European Medicines Agency has validated its applications for accelerated review of lenacapavir, a twice-yearly injectable HIV-1 ...

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.