US FDA approves Gilead's twice-yearly injection for HIV prevention
- The FDA approved Gilead's lenacapavir, marketed as Yeztugo, on June 18, 2025, as a twice-yearly injection to prevent HIV in the U.S.
- This approval followed two phase 3 trials, PURPOSE 1 and 2, that showed 100% prevention in women and adolescent girls and 99.9% in men and gender-diverse groups.
- Gilead's CEO Daniel O'Day called the approval a milestone moment and highlighted the drug's potential to help end the HIV epidemic despite funding cuts risking access.
- Yeztugo carries a list price of $28,218 annually before insurance, and clinical trials reported only 1.2% discontinued due to injection site reactions.
- The approval could revive Gilead's HIV franchise and expand prevention options, though political and pricing challenges may limit both U.S. and global distribution.
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Injection Claimed To Prevent HIV Approved By FDA
The Food and Drug Administration (FDA) approved a twice-yearly injection developed to prevent HIV. The first and only of its kind drug, manufactured by Gilead Sciences, will be sold under the name Yeztugo (lenacapavir). WATCH: #GileadNews: The FDA has approved our injectable HIV-1 prevention medication, making it the first and only twice-yearly #HIV prevention option...
FDA Approves Gilead's 'Game Changing' Twice-Yearly Shot To Prevent HIV Transmission, Critics Slam $28K Price Tag - Gilead Sciences (NASDAQ:GILD)
Gilead's FDA-approved Yeztugo, a twice-yearly injectable HIV PrEP, showed near-perfect trial efficacy but faces backlash over its $28K annual price.
·New York, United States
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