Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

The approval comes amid an expansion of HIV prevention options in the U.S. The U.S. Food and Drug Administration (FDA) has approved the first-ever long-acting injectable drug for HIV prevention ...

The US Food and Drug Administration (FDA) has accepted for review Merck & Co’s New Drug Application (NDA) for ...

HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the ...

If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...

JACKSON, Miss. (WLBT) -A new breakthrough drug for HIV Prevention has been approved by the FDA. The drug is called “Yeztugo” and only needs to be injected twice a year to prevent HIV.

The U.S. Food and Drug Administration (FDA) on June 18 approved a newly developed HIV/AIDS prevention drug that only needs to be taken by injection once every six months. The new drug, lenacapavir ...

Now, the FDA's decision will make the drug, which is being marketed under the brand name Yeztugo, available in the U.S., where 31,000 people are infected with HIV every year.

June 19, 2025 – The FDA has approved the first twice-yearly shot to reduce the risk of HIV infections. Originally approved in 2012 as a treatment for people with HIV that no longer responded to ...

The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent HIV, the creator of the drug, Gilead Sciences, announced on ...