The FDA approved Gilead Sciences’ lenacapavir (commercially Yeztugo), a long-acting injectable pre-exposure prophylaxis (PrEP) treatment against HIV that requires just two injections annually. Clinical trials demonstrated superior efficacy compared to once-daily oral options, showing near-complete prevention of HIV infection. This approval marks a paradigm shift in HIV prevention, providing a more convenient alternative with potential to increase adherence and reduce transmission rates. Gilead’s CEO hailed Yeztugo as a historic breakthrough in the fight against HIV. Pricing and access challenges remain amidst evolving U.S. healthcare and funding landscapes. The drug bolsters Gilead’s HIV portfolio as Biktarvy faces patent expiry in the coming years.