Philips Respironics recalls its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circuit board assemblies...
The U.S. government arrests a Chinese citizen related to a criminal complaint about manufacturing and distributing misbranded medical devices and maki...
FDA approves a BioMarin Pharmaceutical supplemental NDA for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia w...
Federal Register notice: FDA withdraws approval of eight ANDAs after the applicants notified the agency that they were no longer marketed.
FDA adds 171 devices to its list of AI/ML-enabled medical devices.
FDA cautions Indias Nectar Lifesciences about CGMP violations in its production of finished drugs.
The FDA Oncology Center of Excellence explains its OCE Scientific Collaborative regulatory research support efforts focused on nine interest areas and...
FDA clears a Cardio Flow510(k) for the companys FreedomFlow Orbital Atherectomy Peripheral Platform.
