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Sofosbuvir / velpatasvir News
U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 10, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric...
FDA Approves Epclusa (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for...
FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 1, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® ...
FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
July 18, 2017 – The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild...
FDA Medwatch Alert: Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain...
FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
June 28, 2016 – The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For...
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