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Duchenne

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health5 months ago•3 min saved

FDA Requests Halt on Sarepta's Duchenne Gene Therapy Amid Safety Concerns

The FDA is expected to request Sarepta Therapeutics to halt shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, following safety concerns and patient deaths related to liver failure, which may lead to a market withdrawal amid ongoing safety investigations.

via BioPharma Dive|

#duchenne #elevidys #fda

health7 months ago•1 min saved

Sarepta's Duchenne Gene Therapy Linked to Second Patient Death

Sarepta Therapeutics has halted shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, after the death of a second non-ambulatory patient due to acute liver failure, prompting the company to work with experts and the FDA to develop a safer immunosuppressive regimen.

via statnews.com|

#duchenne #elevidys #gene-therapy