In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication now covers adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. This milestone approval distinguishes […]

The U.S. Food and Drug Administration (FDA) has approved GOMEKLIâ„¢ (mirdametinib), SpringWorks Therapeutics, Inc.’s MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) that are not amenable to complete resection. SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company […]