The FDA approved Gilead Sciences’ lenacapavir (Yeztugo), a long-acting injectable for HIV pre-exposure prophylaxis administered twice annually. Clinical trials demonstrated near-complete protection, including a 96% infection reduction compared to standard oral regimens. This represents a landmark shift in HIV prevention logistics, potentially improving adherence and expanding coverage amid a growing U.S. PrEP market. Gilead’s leadership aims to capture majority market share as older drugs face patent expiry.