Pfizer and BioNTech delay their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include young children because data...
FDA clears an Esaote North America 510(k) for its Magnifico Open MRI, a whole-body MRI system.
FDA grants Eli Lilly an emergency use authorization for its monoclonal antibody bebtelovimab and its use in treating Covid-19, including the omicron v...
Taiho Oncology asks FDA to not allow applicants for generic Lonsurf to carve out labeling information from a dedicated Taiho renal study that was a po...
Ardelyx says it is appealing to the FDA Office of New Drugs an appeal denied letter on its tenapanor NDA.
Senate majority leader Chuck Schumer files cloture on FDA commissioner-nominee Robert Califfs nomination, which will likely send it to a Senate floor ...
Federal Register notice: FDA makes available a draft guidance entitled Development of Non-Opioid Analgesics for Acute Pain.
The Axinn law firm asks FDA to put conditions on any approval of Injectafer sNDAs based on three clinical trials the firm says have significant defici...