Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...

Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

Alert EMA Says No to Duchenne Gene Therapy Elevidys The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

Sarepta Therapeutics defies the FDA’s request to stop all shipments of Elevidys; Biogen plops down $2B investment in NC; George Tidmarsh becomes FDA director of CDER.

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