FDA approves Edwards Lifesciences Mitris Resilia valve, a tissue valve replacement specifically designed for the hearts mitral position.
FDA says Magellan Diagnostics is again distributing its LeadCare II blood test that had been part of a 2021 recall for a significant risk of falsely l...
FDA updates its guidance on materials to be submitted to support the issuance of an emergency use authorization for a Covid-19 vaccine.
ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is prioritizing inspections of firms with the highest risk of finding c...
Lupin Pharmaceuticals says an FDA inspection at its Novel Laboratories subsidiary closed with 13 inspection observations.
Outlook Therapeutics files a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration.
Medtronic recalls a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the pote...
FDA says patients and healthcare professionals should not use drugs purporting to be sterile produced by Richardson, TX-based FarmaKeio Superior Custo...