MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

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 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, according to the Merck news release.

MRK launches Phase III trials for its once-monthly HIV prevention pill MK-8527, aiming to rival Gilead's daily PrEP options.

Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...

The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease.

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 twice-yearly injectable drug’s potential could be compromised by the Trump administration’s dramatic cuts to HIV-prevention infrastructure in the U.S.

Why FDA approval of new HIV prevention drug is a big deal The U.S. Food and Drug Administration has approved the drug lenacapavir as a twice-yearly injection to prevent HIV.

FDA Approves New Injection For HIV Prevention The breakthrough drug may help end the HIV/AIDS epidemic, experts say.