The U.S. Food and Drug Administration on 18 June approved Gilead Sciences’ lenacapavir, to be marketed as Yeztugo, making it the world’s first HIV pre-exposure prophylaxis that needs just two injections a year. The decision establishes a new long-acting option for preventing the virus and marks the biggest advance in HIV prevention since daily oral pills were introduced more than a decade ago. Lenacapavir is a capsid inhibitor cleared for adults and adolescents weighing at least 35 kilograms. Late-stage studies showed near-total protection: no infections were recorded among 2,282 cisgender women in sub-Saharan Africa, and infection rates among gay and bisexual men and transgender women fell 89 % versus those taking daily Truvada. The academic journal Science called the shot its 2024 “Breakthrough of the Year.” Gilead set a U.S. list price of US$14,109 per injection, or about US$28,000 a year, far above generic daily pills that cost roughly US$30 a month. Public-health groups warn that the price, along with proposed federal cuts to HIV-prevention budgets, could blunt uptake in the United States despite the drug’s clinical promise. Global momentum has nevertheless accelerated. On 14 July the World Health Organization added lenacapavir to its HIV-PrEP guidelines, citing its potential to help curb the 1.3 million new infections recorded in 2024. Kenya and eight other early-adopter countries intend to begin national roll-outs by 2026, pending local regulatory clearances and training of health workers. To improve access in lower-income markets, Gilead on 9 July reached an agreement with the Global Fund to supply up to two million courses of lenacapavir over three years at cost, ahead of generic production. The company says the deal, combined with WHO endorsement, positions the twice-yearly shot as a cornerstone of efforts to end the HIV epidemic worldwide.