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AstraZeneca says it is preparing an emergency use authorization request for its investigational Covid-19 vaccine AZD1222 after rep...[ Price : $8.95]
FDA launches its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communicatio...[ Price : $8.95]
FDA posts a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on ar...[ Price : $8.95]
FDA gives expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for pat...[ Price : $8.95]
FDA accepts for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis.[ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 11/20/2020.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As...[ Price : $8.95]
Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in...