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Celgene’s Pomalyst Granted Breakthrough Therapy Designation from the FDA for HIV-Positive and Negative Kaposi Sarcoma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma. Kaposi …

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ViiV Submits NDA to the FDA for the First Monthly, Injectable, Two-Drug Regimen of Cabotegravir and Rilpivirine for Treatment of HIV

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, two-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s …

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FDA Approves ViiV’s Dovato, the First, Once-Daily, Single-Tablet, Two-Drug Regimen for Treatment-Naïve HIV-1 adults

LONDON–(BUSINESS WIRE)–ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to …

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Gilead Submits sNDA to the FDA for Once-Daily Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired …

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Janssen Presents Positive Long-Term Efficacy and Safety of Symtuza in Treatment-Naïve Adults with HIV-1

GLASGOW, Scotland–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today unveiled 96-week results from the pivotal Phase 3 AMBER study of SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF)) at HIV Glasgow in Scotland. D/C/F/TAF is a once-daily darunavir-based single-tablet regimen (STR), …

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Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy for Treatment of HIV-1 in Treatment-Naïve Adults

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1490) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, …

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AELIX and Gilead Collaborate to Evaluate a Therapeutic Vaccine and TLR7 Agonist Regimen for HIV Cure

BARCELONA, Spain–(BUSINESS WIRE)–AELIX Therapeutics S.L. (“AELIX”), a clinical-stage biotechnology company specialized in the discovery and development of immunotherapies for HIV infection, today announces that it has entered into a clinical research collaboration with Gilead Sciences, Inc. (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas …

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Merck’s Delstrigo Meets Primary Efficacy Endpoint in Phase 3 Study in Patients with HIV

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from the Phase 3 DRIVE-SHIFT trial evaluating a switch of medication to DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil …

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Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy for the Treatment of HIV-1 in Adults New to HIV Therapy

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy …

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FDA Approves Merck’s Destrigo and Pifeltro, Two New Drugs for Treatment of HIV

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) has approved two new HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 …

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