FDA launches its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communication with the agency an...
FDA posts a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligenc...
FDA gives expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of ag...
FDA accepts for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis.
FDA Review posts the Federal Register notices for the week ending 11/20/2020.
Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Devel...
Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in Combination Drug Re...