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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 ...
GlobalData on MSN7d
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 ...
Morgan Stanley sees FDA approval of GILD's Lenacapavir
Morgan Stanley expects the FDA to approve Gilead Sciences (NASDAQ:GILD)' Lenacapavir (LEN) for HIV prevention (PrEP) on or before its June 19 PDUFA date, a move that the bank believes could drive ...
Pharmabiz1d
EMA validates Gilead’s MAA and EU-Medicines for all application for twice-yearly lenacapavir for HIV prevention
Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST] ...
FiercePharma13d
Gilead, riding high from HIV sales boost, charts course for long-acting PrEP launch
With Gilead Sciences' long-acting lenacapavir unlocking a reinvigorated focus on the pre-exposure prophylaxis (PrEP) market ...
Gilead announces European Medicines Agency validation for lenacapavir
Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization ...
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 ...
Gilead Sciences: Strong Q4 Results And Huge Progress In HIV
Gilead Sciences is rated a Strong Buy due to strong Q4 2024 results and a robust HIV franchise. Check out my 12-month price ...
Bay Area Reporter6d
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 ...
Business Wire2d
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
The EMA validation follows the announcement last week that the U.S. Food and Drug and Administration (FDA) accepted Gilead’s New Drug Applications (NDAs) for lenacapavir for PrEP and will assess ...