FDA accepts a CSL Behring BLA for Hizentra [immune globulin subcutaneous (human) 20% liquid] for treating chronic inflammatory demyelinating polyneuro...
Federal Register notice of correction: FDA corrects a notice that appeared in the Federal Register 10/4/2016 to reflect that two ANDAs are not withdra...
FDA warns Ohio device maker National Biological about Quality System and other violations.
FDA warns Italys Tubilux Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA publishes changes made by the 21st Century Cures Act to how the agency processes requests to recognize a voluntary consensus standard.
CBER says GlaxoSmithKline recalled one lot of Menveo diphtheria conjugate vaccine.
FDA approves Gileads hepatitis C drug Vosevi for adults without cirrhosis or with mild cirrhosis.
FDA releases its latest batch of Warning Letters that includes Center for Reproductive Health, ChemRite CoPac, National Biological Corp. and Tubilux P...