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

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

The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a ...

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

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

Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

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

A multi-national, multi-institutional study led by Weill Cornell Medicine investigators found little natural resistance to a ...

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...

Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug Administration ...

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 ...

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.