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 ...
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 ...
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] ...
Bay Area Reporter7d
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 ...
BLUE Stock Plunges on Update
It was a busy week for the biotech sector. While the fourth-quarter earnings season is nearing the end, other pipeline and regulatory updates were in focus. Recap of the Week’s ...
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 ...