The FDA has approved Gilead Sciences’ lenacapavir (Yeztugo) as the first twice-yearly injection for pre-exposure prophylaxis (PrEP) against HIV. Clinical trials demonstrated nearly 100% efficacy in preventing HIV infections, outperforming daily oral PrEP treatments like Truvada. The long-acting formulation addresses adherence challenges inherent to daily pills, potentially expanding prevention uptake significantly. Yeztugo’s approval marks a milestone in HIV prevention, offering a convenient, durable option with the promise to alter the epidemic's trajectory. The drug is approved for adults and adolescents at risk of sexually acquired HIV infection.