FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organs During Oncology Dr...
FDA clears a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usua...
Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.
FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis.
FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the study director.
FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.
FDA warns Globus Medical about Quality System and Medical Device Reporting violations in its production of the Excelsius GPS surgical robot.
