FDA releases the form FDA-483 with one observation from an inspection at Chinas Wuxi Sta Pharmaceutical contract manufacturing organization.
Abiomed recalls all lots of six models of its Impella heart pump due to a potential risk for impeller blade destruction.
The Vir Biotechnology VIR-2482 investigational influenza A monoclonal antibody vaccine fails to meet the primary and secondary endpoints in a Phase 2 ...
FDA tells the DC federal court there are five reasons why it should dismiss a Norwich suit seeking to force the agency to approve an amended ANDA for ...
FDA clears a MediView XR 510(k) for its XR90 augmented reality-based surgical visualization and navigation platform.
Panelists at a Friends of Cancer Research meeting discuss the next steps to help make circulating tumor DNA available as an early endpoint in cancer r...
FDA clears a University of Utah Orthopedic Innovation Center 510(k) for its Bone Bolt System, an implant for percutaneous bone fracture fixation.
FDA says it is working with Pfizer to monitor the potential for drug shortages after a 7/19 tornado severely damaged Pfizers large sterile injectables...
