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Federal Register notice: FDA determines that Johnson & Johnsons Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effe...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...
Stakeholders comment on an FDA discussion paper on artificial intelligence and machine learning as part of medical device software.
FDA warns OriGen Biomedical about Quality System and Medical Device Reporting violations in its production of dual lumen catheters.
FDA clears an EmCyte 510(k) for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell ...