clinicaltrialsarena9d
Gilead’s lenacapavir under priority review could revolutionise HIV PrEP
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...
GlobalData on MSN12d
Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a ...
This New Drug Could Help End the HIV Epidemic—but US Funding Cuts Are Killing Its Rollout
Lenacapavir, a twice yearly injection that prevents HIV transmission, was named the breakthrough medicine of 2024. But without US foreign aid dollars, its delivery to millions worldwide is under ...
Hosted on MSN5d
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...
Trump’s Funding Cuts Halt Rollout Of HIV Prevention Drug
A groundbreaking injectable designed to curb the global spread of HIV is now at risk of being delayed due to Donald Trump's ...
Rolling Out3d
HIV breakthrough faces critical funding cuts
A revolutionary advancement in HIV prevention technology stands at a critical crossroads as recent policy decisions threaten ...
News Medical12d
New HIV therapy lenacapavir shows high efficacy in Ugandan population
A multi-national, multi-institutional study led by Weill Cornell Medicine investigators found little natural resistance to a ...
Managed Healthcare Executive12d
FDA Accepts NDA for Gilead's New HIV Prevention Shot
Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...
New injectable drug changes fight against HIV | Watch on KHOU 11+
Missed KHOU 11+’s live Q&A on injectable PrEP? Watch on demand as experts discuss this HIV prevention breakthrough and answer ...
Bay Area Reporter11d
Twice-yearly PrEP could be available this summer
Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug Administration ...
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New ...
Business Wire7d
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
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 ...