GILD) Confirms FDA Authorization of Vemlidy for Treatment Of Chronic Hepatitis B Virus Infection – Seneca Globe : senecaglobe

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GILD) Confirms FDA Authorization of Vemlidy for Treatment Of Chronic Hepatitis B Virus Infection – Seneca Globe

GILD) Confirms FDA Authorization of Vemlidy for Treatment Of Chronic Hepatitis B Virus Infection – Seneca Globe

Gilead Sciences Inc. (NASDAQ:GILD) moving in diverse range of trends as shares traded at $77.84 with eases down of -0.80%.Gilead Sciences (GILD) confirmed that FDA authorization of Vemlidy for the treatment of chronic hepatitis B virus infection.Vemlidy 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease.


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FDA Approves New Drug for Chronic HBV Infection

FDA Approves New Drug for Chronic HBV Infection

FDA Approves New Drug for Chronic HBV InfectionVemlidy is a targeted prodrug of tenofovirThe Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide [TAF]; Gilead) for the treatment of adults with hepatitis B virus (HBV) infection with compensated liver disease.The approval of Vemlidy is supported by 48-week data from two international Phase 3 studies among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection.Both studies met their primary endpoint of non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.


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U.S. Food and Drug Administration Approves Gilead's Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

U.S. Food and Drug Administration Approves Gilead's Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.See below for important safety information.

U.S. Food and Drug Administration Approves Gilead's Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection