The approval follows an FDA advisory committee vote in favor of Abbott's TriClip Transcatheter Edge-to-Edge Repair system for repair of severe tricuspid regurgitation.
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.
The approval was based on improved overall and PFS with irinotecan liposome alongside oxaliplatin, fluorouracil, and leucovorin vs gemcitabine plus nab-paclitaxel.
Haleon is recalling some lots of its adult cough syrup Robitussin because of microbial contamination, the U.S. Food and Drug Administration (FDA) has said.