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ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of …

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Exposure to HIV Drug in the Womb May Increase Risk of Microcephaly, Developmental Delays in Children

BETHESDA, Maryland, Nov. 18, 2019 /PRNewswire-HISPANIC PR WIRE/ — Children born to women on HIV therapy containing the drug efavirenz were 2 to 2.5 times more likely to have microcephaly, or small head size, compared to children born to women on regimens of other antiretroviral drugs, according to an analysis …

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FDA Grants De Novo Designation for Vela Diagnostics’ Next Generation Sequencing HIV-1 Genotyping Assay

FAIRFIELD, N.J.–(BUSINESS WIRE)–Vela Diagnostics announced today that it has received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs). The Sentosa® SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, …

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ViiV Submits sNDA to the FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Dovato (dolutegravir and lamivudine) as a switch treatment for …

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FDA Approves Gilead’s Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 3, 2019– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in …

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FDA Approves Merck’s Pifeltro and Delstrigo for Use in Appropriate Adults with HIV-1 who are Virologically Suppressed

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO™ (in combination with other antiretroviral agents) and DELSTRIGO™ (as a complete regimen) that expand their indications to include …

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ViiV Reports Positive Phase 3 Results of Investigational, Long-Acting, Injectable HIV-Treatment Regimen Every 2 Months

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR) of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment …

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FDA Advisory Committee Recommends Approval of Gilead’s Descovy for PrEP

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy®(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) …

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Roche Expands Global Access Program Beyond HIV to Include Diagnostic Tests for Tuberculosis, Hepatitis and HPV

Basel, 22 July 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and middle income country programs where the disease burden is the …

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Gilead Partners with Lyndra Therapeutics for the Development of Ultra-Long-Acting HIV Therapies

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, the company making daily pills a thing of the past, has announced a partnership with Gilead Sciences, Inc. to develop and commercialize ultra-long-acting oral HIV therapies. Gilead will have exclusive rights to Lyndra’s therapeutics platform for ultra-long-acting formulations related to HIV. Lyndra’s ultra-long-acting dosage form has …

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