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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.com on MSNFDA Accepts Merck's Filing for Two-Drug, Once-Daily HIV PillMRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.
Learn more about lenacapavir, the most effective HIV treatment and prevention drug, and how its cost could cause a setback.
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) 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.
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 ...
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 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.
The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.
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