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Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Devel...
Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in Combination Drug Re...
Johnson & Johnson subsidiary Medical Device Business Services agrees to pay $10 million to settle allegations under the False Claims Act over alleged ...
Federal Register notice: FDA updates its ongoing listing of issued and reissued Emergency Use Authorizations for medical devices related to the Covid1...