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US FDA adds strongest warning to Sarepta gene therapy after fatal liver injuries
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US FDA adds strongest warning to Sarepta gene therapy after fatal liver injuries
Nov 14, 2025 11:24 AM

Nov 14 (Reuters) - The U.S. Food and Drug Administration

said on Friday it approved new labeling for Sarepta

Therapeutics' ( SRPT ) 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.

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