Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat ...

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" with the regulator.

US stocks closed mixed on Monday, but the Nasdaq Composite and S&P 500 managed to notch fresh records. Wall Street began a ...

US stocks rose on Monday, with fresh records for the Nasdaq Composite (^IXIC) and S&P 500 (^GSPC) in sight as Wall Street ...

Alert EMA Says No to Duchenne Gene Therapy Elevidys The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

Sarepta Therapeutics defies the FDA’s request to stop all shipments of Elevidys; Biogen plops down $2B investment in NC; George Tidmarsh becomes FDA director of CDER.

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