The Priority Review

Tag

bepirovirsen

1 story

Stories

  1. Approvals

    FDA approves first-of-its-kind chronic hepatitis B treatment

    The FDA approved Hibsago (bepirovirsen) injection for adults without cirrhosis who have been on antiviral therapy for at least six months and have HBsAg levels of 3,000 IU/mL or less. The approval includes the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic.