FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) for treating atypical hemolytic uremic syndrome to inhibit complement-med...
FDA Review posts the Federal Register notices for the week ending 10/18/2019.
FDA Review posts product approval summaries for the week ending 10/18/2019.
FDA clears an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho Vision Analyzer.
Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB.
American Gene Technologies files an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy being developed for el...
FDA says Johnson & Johnson has recalled one lot of its Johnsons Baby Powder (Lot #22318RB) after an agency sample detected asbestos.