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Condition: Atrial Fibrillation
Management: Food and Drug Administration (FDA)
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Total 197 results found since Jan 2013.
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Transcatheter Left Atrial Appendage Closure
Methodist Debakey Cardiovasc J. 2023 May 16;19(3):67-77. doi: 10.14797/mdcvj.1215. eCollection 2023.ABSTRACTAtrial fibrillation is the most common arrhythmia worldwide, placing a large population at risk for potentially disabling ischemic strokes, yet an estimated 50% of eligible patients cannot tolerate or are contraindicated to receive oral anticoagulation. Within the last 15 years, transcatheter options for left atrial appendage closure (LAAC) have provided a valuable alternative to chronic oral anticoagulation for reducing risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. With newer...
Source: Methodist DeBakey Cardiovascular Journal - May 22, 2023 Category: Cardiology Authors: Gordon X Wong Gagan D Singh Source Type: research
