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FDA changes Hepatitis C Devices Categorization SHEM OIRERE
December 17, 2021
To Support Global efforts to test and treat chronic hepatitis C has received a major boost from the Food and Drug Administration (FDA) after the US-based regulator issued a final order for the reclassification...
Veklury Drives 2Q Growth for Gilead contractpharma
August 02, 2021
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
Changes to the Mavyret Product Label for Pediatrics americanpharmaceuticalreview
June 16, 2021
The FDA has approved Mavyret (glecaprevir and pibrentasvir) oral pellets (100mg/40mg) for the treatment of pediatric patients 3 to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection ...
New Health Trends® Study by Quest Diagnostics in Collaboration with CDC Reveals Concerning Decreases in Hepatitis C Testing and Treatment During First Months of COVID-19 Pandemic prnewswire
May 12, 2021
A new Quest Diagnostics Health Trends® report developed in collaboration with the Centers for Disease Control and Prevention (CDC) found that the COVID-19 pandemic reduced routine hepatitis C virus (HCV) testing and treatment.
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.
EU Marketing Authorisation change for Maviret pharmatimes
March 10, 2020
The European Commission has granted AbbVie permission to change the Marketing Authorisation for Maviret (glecaprevir/pibrentasvir) to eight weeks of treatment.
European Commission Grants AbbVie Marketing Authorization for Shorter MAVIRET Treatment americanpharmaceuticalreview
March 09, 2020
AbbVie announced that the European Commission has approved a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration ...
Guideline Updated for Prevention, Management of Hep C in CKD drugs
September 24, 2019
In a synopsis of the 2018 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline, published online in the Annals of Internal Medicine, updated recommendations are presented for the prevention...

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