GILD News & Events

Gilead Sciences announced the U.S. FDA accepted its supplemental New Drug Application for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for the prevention of HIV as pre-exposure prophylaxis. The FDA has assigned a Prescription Drug User Fee Act action date of February 2, 2027.

Gilead applauds the leadership of the Government of South Africa and the Global Fund for accelerating access to lenacapavir, a long-acting HIV prevention medication. This marks an important step toward expanding access to lenacapavir for communities most affected by HIV. "South Africa is at the heart of global efforts to end HIV. With the country's launch of lenacapavir, there is now an opportunity to rapidly accelerate progress," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences. "Through partnerships with country leadership, the Global Fund, and the U.S. State Department via PEPFAR, Gilead is working to bring lenacapavir to the communities most in need, ahead of the broad rollout of generic versions of the medicine."