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.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

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Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday ...

Asian markets are mixed after U.S. stock indexes hit new records on Monday. Oil prices fell and U.S. futures were little changed. Japan's Nikkei 225 dropped 0.3% after an initial surge, following ...

Verizon Communications helped lead the way and rose 4%. The telecom giant reported a stronger profit for the latest quarter ...

Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...

U.S. stocks moved higher on Monday as optimism around earnings overshadowed any investor fears over the latest developments ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% ...