Y-mAbs Therapeutics plans to re-submit a BLA on omburtamab for treating patients with CNS/leptomeningeal metastases from neuroblastoma after getting p...
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Federal Register notice: FDA makes available a draft guidance entitled Development of Non-Opioid Analgesics for Acute Pain.