Federal Register notice: FDA announces an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation to treat Clostridium ...
Researchers say they could not find a clear threshold of magnitude of treatment effect that would lead FDA to not request randomized clinical trials i...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Edwards Lifesciences Pericardial Aortic Biopros...
FDA grants EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in certain patients with metastatic non-sm...
FDA clears a HeartFlow 510(k) for the HeartFlow Planner, a real-time virtual modeling tool for coronary artery disease intervention.
Federal Register notice: FDA announces an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss an Amarin Pharma supplemental...
Bloomberg Businessweek takes a lengthy review of the FDA involvement in the case of contaminated valsartan and other hypertension drugs.
A CNN opinion column calls for patent reform as a means of helping to address high drug prices.