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The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...
Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.