Posted by Michael Wonder on 16 Jun 2026
US FDA accepts Gilead’s application for investigational once weekly oral Yeztugo, potentially the first long-acting pill for HIV prevention
15 June 2026 - Gilead Sciences today announced the US FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablet as a potential once weekly oral formulation for the prevention of HIV as pre-exposure prophylaxis.
The FDA has assigned a PDUFA action date of 2 February 2027.
