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

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

Aug 30 (Reuters) - Drugmaker Merck & Co Inc said on Thursday the U.S. Food And Drug Administration approved two of its oral medicines to treat HIV patients. U.S. regulators approved Delstrigo, a ...

In 2022, the Food and Drug Administration (FDA), along with other health organizations, approved the drug lenacapavir as a groundbreaking HIV/AIDS treatment. The FDA, as of June 18, 2025, has now ...

The Food and Drug Administration on Wednesday approved a powerful new drug that provides almost complete protection against HIV infections. The twice-yearly injection, known as lenacapavir, offers ...

The drug, Apretude, is approved for at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV, the FDA announced Monday.

The Food and Drug Administration has just approved a preventative HIV drug widely regarded as a breakthrough. On Wednesday afternoon, the FDA approved Gilead Sciences’ lenacapavir as a more ...

FDA approves powerful HIV drug that nearly eliminated spread in clinical trials The twice-yearly injectable drug’s potential could be compromised by the Trump administration’s dramatic cuts to ...

Isentress would compete with Pfizer's Selzentry, another novel HIV treatment the FDA approved last month for drug-resistant HIV patients. Merck's drug could be more attractive to doctors and ...

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.

FDA approves powerful HIV drug that nearly eliminated spread in clinical trials The twice-yearly injectable drug’s potential could be compromised by the Trump administration’s dramatic cuts to ...