Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.
FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental health issues, Reut...
ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devices.
FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metastatic HER2-positive bi...
FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.
FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center.
Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency Use Authorization (...
CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk re...
