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.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support P...
Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C ...
