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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
- Merck and Moderna plan to seek approval for personalized mRNA melanoma vaccine after Phase 3 shows delayed recurrenceAt the 2026 STAT Summit, Merck and Moderna outlined their partnership to combine Keytruda with a personalized mRNA cancer vaccine aimed at melanoma patients. In a large Phase 3 trial, the vaccine…