Gilead Sciences Inc. has announced ongoing regulatory reviews and new milestones in the global expansion of lenacapavir for PrEP, a breakthrough HIV prevention medication. Following approvals by the U.S. Food and Drug Administration (FDA) and the European Commission, Gilead has filed for regulatory review in Australia, Brazil, Canada, South Africa, and Switzerland. The company is also preparing submissions in Argentina, Mexico, and Peru. Additionally, Gilead is utilizing a positive opinion from the EU-Medicines for all (EU-M4all) to facilitate accelerated review in low- and middle-income countries, covering 18 nations that represent 70% of the HIV burden. These efforts are further supported by a strategic partnership with The Global Fund to Fight AIDS, Tuberculosis and Malaria to potentially supply lenacapavir for PrEP to up to two million people in primarily low- and lower-middle-income countries.