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FDA to review MSD’s doravirine/islatravir NDA for HIV-1
15 Jul 2025 12:14 GMT
… US Food and Drug Administration (FDA) has accepted MSD … trial MK-8591A-051 and to bictegravir/emtricitabine/tenofovir … comorbidities or navigating complex medication regimens. We believe … for the prestigious Pharmaceutical Technology Excellence Awards …
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WHO Adds Lenacapavir to Its HIV PrEP Recommendations Amid Underutilization of PrEP and Severe PEPFAR Funding Cutbacks | IAS 2025
15 Jul 2025 16:23 GMT
… the FDA on June 18 based on clinical trials showing … of treatment guidelines changed a preference for tenofovir disoproxil fumarate … infectious disease and internal medicine specialist at the University … viral load on three-drug antiretroviral regimens and …
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MSD progresses once-monthly HIV PrEP into Phase III
15 Jul 2025 12:53 GMT
… against daily emtricitabine/tenofovir disoproxil fumarate (FTC… on a monthly PrEP pill.
MSD Research Laboratories’ … Director-General describing the drug as the “next best … trial readout, the company is advancing the candidate to Phase III trials …
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“Radical Transparency” or Not? FDA Releases Hundreds of Decision Letters to the Public
11 Jul 2025 14:03 GMT
… transparency”, the US Food and Drug Administration (FDA) has made over 200 … of bringing cures and meaningful treatments to patients faster.”
The agency … to AB pharmaceuticals for the product efavirenz, lamivudine and tenofovir disoproxil fumarate …
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Merck application for two drug regimen for adults with virologically suppressed HIV 1 infection under USFDA review
11 Jul 2025 12:32 GMT
… U.S. Food and Drug Administration (FDA) has accepted for … double-blind trial MK-8591A-052. Across both trials, the … as the anchor medicine in the treatment regimens based on … DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) in the U …
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FDA Accepts NDA for Investigational HIV Regimen, Doravirine/Islatravir
11 Jul 2025 04:52 GMT
… today. A Prescription Drug User Fee Act (PDUFA … tenofovir alafenamide (BIC/FTC/TAF). Efficacy for both trials … nucleoside reverse transcriptase inhibitor medication, which blocks reverse transcriptase … novel oral once-weekly treatment for HIV.
“The …
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FDA to Evaluate Merck’s Doravirine, Islatravir Regimen for HIV-1
10 Jul 2025 23:45 GMT
… .1 The FDA set a Prescription Drug User Fee … 052 (NCT05630755). In both trials, doravirine/islatravir … ;tenofovir alafenamide across both studies. There was no treatment- … comorbidities or navigating complex medication regimens. We believe doravirine …
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US FDA accepts Merck's NDA for doravirine/islatravir, an investigational, once─daily, oral, two─drug regimen to treat adults with virologically suppressed HIV─1 infection
11 Jul 2025 03:46 GMT
… the US Food and Drug Administration (FDA) has accepted for … bictegravir/emtrictabine/tenofovir alafenamidei [BIC/FTC… double-blind trial MK-8591A-052. Across both trials, the safety … as the anchor medicine in the treatment regimens based on …
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FDA Accepts New Drug Application for Merck’s HIV Treatment, Doravirine/Islatravir
10 Jul 2025 17:40 GMT
… or navigating complex medication regimens,” Eliav Barr … Trials Parameters and Results
The FDA acceptance for the once-daily, oral, treatment … active-controlled clinical trial evaluating the efficacy … #47;emtrictabine/tenofovir alafenamidei [BIC/ …
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Antiretroviral drugs in South Africa’s rivers raise environmental concerns
10 Jul 2025 19:25 GMT
… consumption, including acyclovir didanosine and tenofovir, whereas other compounds undergo … to 90% of orally consumed pharmaceutical drugs reach wastewater in one … concentrations in water, improving wastewater treatment technologies, and conducting further …
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