Pharmaceutical Technology on MSN1d
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced EMA validation for a parallel accelerated review of lenacapavir’s MAA and EU-M4all applications ...
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 ...
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 MSN8d
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 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 ...
pharmaphorum7d
FDA sets June date for Gilead's twice-yearly HIV PrEP
Analysts at RBC Capital Markets have predicted twice-yearly lenacapavir could become a $2 billion product, and become a key ...
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] ...
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 ...
Bay Area Reporter7d
Twice-yearly PrEP could be available this summer
Gilead Chief Medical Officer Dr. Dietmar Berger. Photo: Courtesy Gilead Sciences Inc. Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug ...
Yahoo Finance5d
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.
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 ...