Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
Provides pain relief for more than 30 conditions, including chronic back pain, arthritis, and sports injuries
If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant
AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life
According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
Full approval will depend on verification of clinical benefit in a confirmatory trial
The platform aims to serve doctors, consumers, and healthcare facilities by providing AI-assisted clinical decision tools, personalized health insights, and improved diagnostic capabilities
Healthcare and insurance are not parallel systems; they are interdependent pillars of patient trust
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
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