GlobalData on MSN1d
Gilead’s lenacapavir applications for HIV gain EMA validation
The latest announcement follows the recent US Food and Drug Administration (FDA) acceptance of the company’s new drug ...
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 ...
The Pharma Letter2d
Analyst predicts Gilead’s lenacapavir could revolutionize HIV prevention
US antivirals giant Gilead Sciences recently announced that the US Food and Drug Administration (FDA) has accepted its New ...
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] ...
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 ...
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 ...
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 ...
PharmiWeb7d
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 Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly ...
Managed Healthcare Executive7d
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 ...
Gilead Ups 2025 Outlook, Eyes Lenacapavir Launch For HIV Prevention
Gilead reported Q4 adjusted EPS of $1.90, exceeding estimates, with HIV sales up 16%. The company raised guidance and expects a key HIV drug launch in 2025.
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 ...