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FDA sets June date for Gilead's twice-yearly HIV PrEP

Summary by Pharmaphorum

Gilead's already dominant position in HIV PrEP could be extended if the FDA approves a new twice-yearly injectable product later this year

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Pharmaphorum

FDA sets June date for Gilead's twice-yearly HIV PrEP

Gilead's already dominant position in HIV PrEP could be extended if the FDA approves a new twice-yearly injectable product later this year

4 days ago

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pipelinereview

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review - Pipelinereview

– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV Prevention Choice – – FDA to Review Applications Under Priority Review, with a PDUFA Date of June 19, 2025 – – Gilead Also Recently Submitted Applications for Lenacapavir for PrEP to the European Medicines Agency That Will Be Reviewed Under Accelerated Assessment Review Timeline – FOSTER CITY, CA, USA I February 18, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced…

4 days ago

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