FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or misleading and viol...
FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug development and eval...
FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Micro Capillary Collect...
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.
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could r...
