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 ...
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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 ...
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HIV breakthrough faces critical funding cuts
A revolutionary advancement in HIV prevention technology stands at a critical crossroads as recent policy decisions threaten ...
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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 ...
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 ...
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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 ...
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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 ...
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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 ...
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Gilead's Lenacapavir For HIV Prevention Gets Fast-Track Review From European Regulators
(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 ...
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Twice-Yearly Lenacapavir Gets Priority Review For HIV PrEP
The Food and Drug Administration (FDA) has accepted under Priority Review the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, for the prevention of HIV as ...
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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 submissions for lenacapavir for human immunodeficiency virus (HIV) prevention.