The FDA has approved a new, twice-yearly PrEP injection from pharmaceutical giant Gilead. The drug is lenacapavir. The twice-yearly formulation has the brand name Yeztugo.

Yeztugo (lenacapavir) is now the first and only HIV prevention option approved by the U.S. FDA that offers protection for six months. Yeztugo received FDA approval under Priority Review.

The Food and Drug Administration has approved the world's only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday.

Updated: Jun 18, 2025 / 03:56 PM EDT WASHINGTON (AP) — The U.S. has approved the world’s only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday.

Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans ...

It's the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option.

That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023 ...

In two groundbreaking clinical trials in 2024, Gilead's injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That's a less frequent dosage than ...

FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new option By Annika Kim Constantino, CNBC • Published June 18, 2025 • Updated on June 18, 2025 ...

This photo provided by Gilead Sciences shows packaging for the company's HIV prevention medication, Yeztugo, (lenacapvir) at a manufacturing facility in La Verne, Calif., in June 2025.