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Sarepta, gene therapy and FDA

Reuters on MSN · 14h

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the approval of Elevidys, following mounting regulatory scrutiny and two recent patient deaths linked to the company's gene therapy.

Bloomberg on MSN · 13h

FDA Investigates Death of Boy Who Got Sarepta’s Gene Therapy

US regulators said they are investigating the death of an 8-year-old boy who received a gene therapy from Sarepta Therapeutics Inc.

Associated Press News on MSN · 6d

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

EMA Says No to Duchenne Gene Therapy Elevidys

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

Fierce Pharma1d

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

Investor's Business Daily on MSN1d

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.

Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...

4d

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

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