- FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reportsThe FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
- FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancerThe U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…fda press · 5d agoApprovalPositive