Gilead Sciences attained FDA approval for Yeztugo (lenacapavir), the first twice-yearly injectable pre-exposure prophylaxis (PrEP) drug for HIV prevention. Clinical trials demonstrated up to 100% efficacy in cisgender women and strong protection across diverse populations including transgender and nonbinary individuals. The extended dosing interval aims to overcome adherence challenges associated with daily oral PrEP, potentially advancing HIV prevention globally. This regulatory milestone comes amid broader public health efforts to control HIV transmission with innovative long-acting therapeutics.