FDA clears an Applied BioCode 510(k) to permit the use of Roches MagNA Pure 96 Extraction System with the high throughput BioCode MDx-3000 and Gastroi...
FDA has cleared a CorMatrix Cardiovascular 510(k) for the Cor Patch, indicated for epicardial tissue support and repair in adult patients.
Catalyst Pharmaceuticals sues FDA over its approval of Jacobus Pharmaceuticals Rezurgi for treating Lambert-Eaton Myasthenic Syndrome in pediatric pat...
Bloomberg News says a letter accidentally made public indicates the Justice Department and Novartis may be close to terms to settle a six-year-old whi...
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.
Eli Lilly says data from its REWIND study, a cardiovascular outcomes trial involving diabetes drug Trulicity (dulaglutide), showed a significant 12% r...
Federal Register notice: FDA determines that Johnson & Johnsons Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effe...
Federal Register notice: FDA is seeking comments on an information collection extension entitled Investigational Device Exemptions Reports and Records...