Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubruti...
FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondicherry, Puducherry, ...
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss dr...
FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigational cell therapy for...
A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert judgment, with limit...
