FDA starts kicks off review of Gilead's weekly HIV pill

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The FDA has begun reviewing Gilead’s once-weekly oral HIV PrEP pill, Yeztugo, and is expected to make a decision by February 2 next year. If approved, the pill would expand PrEP options for people at risk of HIV and could become the first long-acting oral therapy in this category. Gilead is positioning the drug as an additional option alongside its injectable Yeztugo and daily oral Descovy, while facing competition from generics and ViiV’s Apretude. The company is also advancing a separate once-weekly HIV treatment pill with MSD based on positive phase 3 trial results.

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