[ Price : $8.95]
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondi...[ Price : $8.95]
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug...[ Price : $8.95]
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for ...[ Price : $8.95]
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affe...[ Price : $8.95]
CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draf...[ Price : $8.95]
FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigatio...[ Price : $8.95]
A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert ...[ Price : $8.95]
FDA accepts for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cel...