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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 firstwordpharma
June 11, 2021
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that FDA has approved an expansion of the pediatric indication of Epclusa® for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age
EU OKs paediatric use of Gilead's Epclusa pharmatimes
September 03, 2020
The European Commission (EC) has expanded marketing authorisation for Gilead's Epclusa (sofosbuvir/velpatasvir/sofosbuvir) to include the treatment of children with chronic hepatitis C infection (HCV).
FDA OKs Gilead’s paediatric hep C drug pharmatimes
March 24, 2020
Gilead has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg.
Gilead gets FDA approval for Epclusa to treat hepatitis C in children pharmaceutical-technology
March 23, 2020
Gilead Sciences has received approval from the US Food and Drug Administration (FDA) to use Epclusa for treating chronic hepatitis C infection (HCV) in children aged six years and above.
Included in China’s National Essential Drugs List, Can Epclusa Get a Second Wind in China? (2) 1℃
November 21, 2018
I mentioned in previous articles that genotypes of Chinese hepatitis C patients are mainly 1b and 2a/c, with the number of hepatitis C patients of about 26 million in total but treatment rate of less than 0.5%! The market space is huge.
Included in China’s National Essential Drugs List, Can Epclusa Get a Second Wind in China? (1) 1℃
November 20, 2018
The 2018 Edition National Essential Drugs List of China was officially published on October 25, 2018, which attracts extensive attention of the industry.
Gilead to release generic versions of hep C meds over a decade before patent expiry pharmafile
September 29, 2018
Gilead has announced its intention to undercut itself by releasing generic versions of its blockbuster drugs for the treatment of hepatitis C, Epclusa (sofosbuvir/velpatasvir)...
Darzalex, Epclusa will be funded on NHS Scotland pharmatimes
October 11, 2017
Patients in Scotland with multiple myeloma and those with some types of hepatitis C have won NHS access to new treatment options after the Scottish Medicines Consortium backed routine use of Janssen’s Darzalex and Gilead’s Epclusa.