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- FDA issues early alert for Edwards Lifesciences’ mitral valve delivery system after reported death, injuryThe FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.Fierce Biotech · 4d ago↗ source
- Vanda pauses social anxiety program after ex-Novartis asset flunks phase 3 studyA phase 3 trial of Vanda Pharmaceuticals’ social anxiety disorder drug candidate has missed its primary endpoint, prompting the company to put the program on hold.