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An alternative to using standard glucocorticoids is the synthetic dissociative steroid vamorolone (Agamree), which was ...
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
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The story of Sarepta's Duchenne gene therapyThe last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...
The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...
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Shipments of Duchenne Gene Therapy to Resume After FDA Review of Patient DeathSarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver ...
Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to ...
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
REGENXBIO Inc. (NASDAQ:RGNX) is one of the biotech stocks to buy according to Wall Street analysts. On July 10, REGENXBIO ...
A senior official at the US Food and Drug Administration has suddenly resigned after only three months in the job. Vinay Prasad’s departure followed controversy over a treatment for Duchenne muscular ...
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