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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 ...
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Zacks Investment Research on MSNMerck Starts Phase III Studies on Once-Monthly Pill for HIV PreventionMerck MRK recently launched two late-stage clinical studies to evaluate MK-8527, its investigational once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP). The EXPrESSIVE-11 study, which ...
Why FDA approval of new HIV prevention drug is a big deal 02:25. The U.S. Food and Drug Administration has approved the drug lenacapavir as a twice-yearly injection to prevent HIV.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the ...
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 ...
If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...
The US Food and Drug Administration (FDA) has accepted for review Merck & Co’s New Drug Application (NDA) for ...
A pharmacist holds a vial of lenacapavir, the injectable drug that prevents HIV infection. On June 18, the FDA approved the drug for use in the U.S. Nardus Engelbrecht/AP hide caption ...
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 ...
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.
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