The Food and Drug Administration has approved Gilead Sciences’ lenacapavir (Yeztugo), a long-acting injectable drug administered twice yearly to prevent HIV infection in at-risk adults and adolescents. Clinical trials demonstrated zero infections in a study of over 5,000 women and up to 96% reduction compared to background rates, representing a significant advancement in HIV pre-exposure prophylaxis (PrEP). This approval could dramatically improve adherence compared to daily oral regimens. However, uncertainties remain regarding access and affordability, given federal funding fluctuations and the drug’s high cost per dose. Gilead’s CEO has expressed commitment to global deployment and next-generation formulations including annual dosing.