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Astellas Gains Fast Track Designation for Acute Kidney Injury Treatment

Astellas Gains Fast Track Designation for Acute Kidney Injury Treatment

The U.S. Food and Drug Administration has granted its Fast Track designation to Astellas's investigational drug ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury following coronary artery bypass or valve surgery. Accelerated approval pathways have a major impact on reducing the time to clinic and market for new drugs, but such expedited clinical trials programs have their own complications. Yourway is experienced in facilitating streamlined, efficient clinical trials to support Fast Track clinical programs.

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