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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 ...
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 ...
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 ...
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] ...
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 ...
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 ...
emjreviews.com1d
EMA grants accelerated review to Gilead’s PrEP drug
The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...
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 Reporter6d
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 ...