https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gileads-twice-yearly-injection-hiv-prevention-2025-06-18/ Skip to main content Exclusive news, data and analytics for financial market professionals Learn more aboutRefinitiv * World Browse World + Africa + Americas + Asia Pacific + China + Europe + India + Israel and Hamas at War + Japan + Middle East + Ukraine and Russia at War + United Kingdom + United States + Reuters NEXT * Business Browse Business + Aerospace & Defense + Autos & Transportation + Davos + Energy + Environment + Finance + Healthcare & Pharmaceuticals + Media & Telecom + Retail & Consumer + Future of Health + Future of Money + Take Five + World at Work * Markets Browse Markets + Asian Markets + Carbon Markets + Commodities + Currencies + Deals + Emerging Markets + ETFs + European Markets + Funds + Global Market Data + Rates & Bonds + Stocks + U.S. Markets + Wealth + Econ World * Sustainability Browse Sustainability + Boards, Policy & Regulation + Climate & Energy + Land Use & Biodiversity + Society & Equity + Sustainable Finance & Reporting + The Switch + Reuters Impact + COP29 * Legal Browse Legal + Government + Legal Industry + Litigation + Transactional + US Supreme Court * Commentary Browse Commentary + Breakingviews + ROI: Reuters Open Interest * Technology Browse Technology + Artificial Intelligence + Cybersecurity + Space + Disrupted * Investigations * More Sports + Athletics + Baseball + Basketball + Cricket + Cycling + Formula 1 + Golf + NFL + NHL + Soccer + Tennis ScienceLifestyleGraphicsPictures Wider ImagePodcasts + Reuters World News + Reuters Econ World + Viewsroom + The Big View LiveFact CheckVideoSponsored Content + Reuters Plus + Press Releases My News Register US FDA approves Gilead's twice-yearly injection for HIV prevention By Deena Beasley and Julie Steenhuysen June 18, 20256:36 PM UTCUpdated ago * * * * * * * * Gilead Sciences pharmaceutical company is seen in California Gilead Sciences pharmaceutical company is seen in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo Purchase Licensing Rights, opens new tab * Companies * Gilead Sciences Inc Follow * U.S. Food and Drug Administration Follow June 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences (GILD.O), opens new tab lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Gilead said the drug will be sold under the brand name Yeztugo. Sign up here. Investors and AIDS activists had been eagerly awaiting the regulatory decision for a drug some have said could help end the 44-year-old HIV epidemic. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects 1.3 million people a year. The academic journal Science dubbed the experimental pre-exposure prophylaxis (PrEP) drug the 2024 Breakthrough of the Year. "This is a milestone moment," said Gilead Chief Executive Daniel O'Day of the approval. "We believe that lenacapavir is the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books." Gilead has plans for a rapid launch in the United States as well as a wider rollout of the drug in collaboration with global partners. Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot Our Standards: The Thomson Reuters Trust Principles., opens new tab * Suggested Topics: * Healthcare & Pharmaceuticals * Approvals * Regulatory * Regulatory Oversight * * * * * Purchase Licensing Rights Read Next * A combination image shows an injection pen of Zepbound, Eli Lilly's weight loss drug, and boxes of Wegovy, made by Novo Nordisk Healthcare & PharmaceuticalscategoryFat, not muscle: Drugmakers in race for next weight-loss breakthrough 9:20 PM UTC * Updated ago * Measles scare in New York Healthcare & PharmaceuticalscategoryKennedy's new US vaccine panel to discuss measles shot for children 10:26 PM UTC * Updated ago * Outbreak of bird flu in Brazil Healthcare & PharmaceuticalscategoryBrazil declares itself bird flu 'free', aims to resume exports 8:10 PM UTC * Updated ago * Boxes of Wegovy made by Novo Nordisk are seen at a pharmacy in London Healthcare & PharmaceuticalscategoryUS judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list 6:24 PM UTC * Updated ago LSEG Workspace Business * U.S. Federal Reserve Chair Jerome Powell holds a press conference, in Washington Fed's Powell says central bank still has the needed data to do its work Businesscategory * June 18, 2025 * 10:33 PM UTC * ago Federal Reserve Chair Jerome Powell made a plea on Wednesday for the government not to cut back too aggressively on its efforts to collect data on the economy because the information it collects strongly benefits the entire nation. * Illustration shows Microsoft logo BusinesscategoryMicrosoft prepared to abandon high-stakes talks with OpenAI, FT reports 10:28 PM UTC * Updated ago * Circle Internet Group, the issuer of one of the world's biggest stablecoins, holds IPO at the NYSE in New York BusinesscategoryCircle, Coinbase shares soar as Senate clears path for stablecoin regulation 10:16 PM UTC * Updated ago * A Microsoft logo is seen in Issy-les-Moulineaux near Paris World at WorkcategoryMicrosoft planning thousands of job cuts aimed at salespeople, Bloomberg News reports 10:10 PM UTC * Updated ago * Bird flu in top chicken exporter Brazil triggers trade bans Healthcare & PharmaceuticalscategoryWhich countries are restricting chicken from Brazil due to bird flu 10:09 PM UTC * Updated ago Site Index Browse * World * Business * Markets * Sustainability * Legal * Breakingviews * Technology * Investigations * Sports * Science * Lifestyle About Reuters * About Reuters, opens new tab * Advertise with Us, opens new tab * Careers, opens new tab * Reuters News Agency, opens new tab * Brand Attribution Guidelines, opens new tab * Reuters and AI, opens new tab * Reuters Leadership, opens new tab * Reuters Fact Check * Reuters Diversity Report, opens new tab Stay Informed * Download the App (iOS), opens new tab * Download the App (Android), opens new tab * Newsletters * Subscribe Information you can trust Reuters, the news and media division of Thomson Reuters, is the world's largest multimedia news provider, reaching billions of people worldwide every day. 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