FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel disease pouchitis.
FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluating the need for regul...
FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.
FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact and Standard endotrac...
UniQure says it will meet soon with FDA to discuss potential expedited clinical development pathways and accelerated approval after reporting positive...
FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.
Inspire Medical Systems recalls its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can disrupt therapy.
Federal Register notice: FDA makes available a revised draft guidance entitled Addressing Misinformation About Medical Devices and Prescription Drugs:...
