Business Wire21d
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s ...
PharmiWeb26d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
--(BUSINESS WIRE)-- 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 ...
Business Wire27d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
“Today, we are one step closer to introducing the first-ever twice-yearly HIV prevention choice that ... application to the European Medicines Agency (EMA) for lenacapavir for PrEP.
PharmiWeb24d
Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis
The EC’s decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2024 ... life-threatening diseases, ...
MIT Technology Review2d
This annual shot might protect against HIV infections
Promising results from an early-stage trial suggest that lenacapavir injections might offer long-lasting protection.
Yahoo Finance20d
Gilead’s lenacapavir applications for HIV gain EMA validation
"Gilead’s lenacapavir applications for HIV gain EMA validation" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been ...
Pharmabiz19d
EMA validates Gilead’s MAA and EU-Medicines for all application for twice-yearly lenacapavir for HIV prevention
Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and EU-Medicines for all ...
Kuensel Online5d
HIV: Increased detection points to growing awareness
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News Medical5d
Dementia risk higher among adults with HIV in Malawi
Adults living with HIV in Malawi are more than twice as likely to also have dementia compared to those without HIV, according to a new study by a team of US and Malawian researchers. Their ...
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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 lenacapavir’s marketing authorisation application (MAA) and EU-Medicines for ...