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Davy James
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Andrew Studna
Editor
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Michael Christel
Group Managing Editor
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Miranda Schmalfuhs
Group Social Media Editor
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FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.