For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). The FDA’s investigation has concluded that the death of the 8-year-old boy is unrelated to the gene therapy product itself . …
Read More »Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S. Sarepta Therapeutics In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy statnews.com Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy Fierce Biotech Sarepta shares plunge 40% as future of its gene therapy appears at risk CNBC Sarepta Therapeutics stock sinks …
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Meta says it won’t sign the European Union’s artificial intelligence code of practice agreement, warning that “Europe is heading down the wrong path on AI.” The code published by the EU on July 10th is a voluntary set of guidelines to help companies follow the AI Act’s rules around general-purpose AI before they come into effect in a few weeks. …
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