US FDA adds strongest warning to Sarepta gene therapy after fatal liver injuries
14/11/2025 19:04
Nov 14 (Reuters) - The U.S. Food and Drug Administration said on Friday it approved new labeling for Sarepta Therapeutics'SRPT.O gene therapy Elevidys that includes its most serious safety warning and restricts use of the treatment to walking patients 4 years of age and older with Duchenne muscular dystrophy. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Alan Barona) ((Padmanabhan.Ananthan@thomsonreuters.com;))
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