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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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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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