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FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental...[ Price : $8.95]
ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devic...[ Price : $8.95]
FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metasta...[ Price : $8.95]
FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.[ Price : $8.95]
FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Comm...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency...[ Price : $8.95]
CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by compa...[ Price : $8.95]
Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for re...