The European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral therapy for the treatment of acute hepatitis C virus infection in adults and children aged 3 years and older. With this approval, Maviret is now the only treatment approved in the European Union for both acute and chronic HCV infection.
FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
