FDA Halts Sarepta’s ELEVIDYS Distribution and Clinical Trials After Three Deaths Linked to Gene Therapy

On July 18, 2025, the U.S. Food and Drug Administration (FDA) took decisive action against Sarepta Therapeutics following the deaths of three individuals who had received the company’s gene therapy…

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The FDA Has Awarded Fast Track Designation to an Investigational Drug For Certain Forms of Ovarian Cancer
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The FDA Has Awarded Fast Track Designation to an Investigational Drug For Certain Forms of Ovarian Cancer

The United States FDA has awarded Fast Track Designation to the investigational drug AVB-S6-500 for the potential treatment of platinum-resistant recurrent ovarian cancer. You can find out more detailed information…

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FDA Fast Tracks First Possible Treatment for Familial Adenomatous Polyposis

In late September, Food and Drug Administration designated "fast track" status to the research and development of CPP-1X/sul for adults diagnosed with Familial Adenomatous Polyposis (FAP). Overseeing the project are Cancer…

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