Sarepta Elevidys FDA Challenges

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FDA, Sarepta and gene therapy

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

EconoTimes · 1d

FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy

· 6d

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

Investing.com South Africa2d

Sarepta stock falls after Elevidys fails to get backing by EU regulators

The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...

BioPharma Dive2d

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

5don MSN

Sarepta’s Elevidys Halted at Children’s Hospital Los Angeles

Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in ...

10d

Sarepta Therapeutics' Reorganization Boosts Investor Confidence

Sarepta agrees to FDA's black box warning and announces major restructuring, including job cuts and cost-saving measures to ...

Reuters1mon

FDA investigates patient deaths after treatment with Sarepta's gene ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

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