[ 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 articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the ag...[ Price : $8.95]
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic ca...[ Price : $8.95]
FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in ped...