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 investigational, once-daily, oral, two-drug, single-tablet regimen of ...

The U.S. Food and Drug Administration (FDA) has approved the first-ever long-acting injectable drug for HIV prevention. Until this week, the only FDA-licensed and approved medications for HIV pre ...

The FDA has approved the first twice-yearly shot to reduce the risk of HIV infections.

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

Utah biochemist Wesley Sundquist has achieved yet another milestone with the Food and Drug Administration approval of an antiviral drug for HIV prevention based on his findings.

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 ...

FDA Approves Breakthrough HIV Drug, but It Could Be Hard to Access Learn more about lenacapavir, the most effective HIV treatment and prevention drug, and how its cost could cause a setback.

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

The FDA has approved Yeztugo for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg.

The injectable HIV prevention treatment Yetzugo, made by Gilead Sciences, has received FDA approval, offering a twice-yearly alternative to daily medications.