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Quantitative muscle ultrasound correlates strongly with ambulatory and timed function tests in Duchenne muscular dystrophy, ...
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
European Medicines Agency recognizes potential of lead compound MP1032 in addressing a high unmet medical need in Duchenne Muscular Dystrophy (DMD)Designation is paving the way for safer long-term ...
After our editorial, the agency relents to allow a Duchenne treatment.
Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...
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MedPage Today on MSNShipments 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 ...
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In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...
Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...
Sarepta Therapeutics (Nasdaq: SRPT) has been cleared by the American medicines regulator to resume shipments of its gene ...
Apellis Pharmaceuticals won approval from the FDA to expand the use of its drug Empaveli to include treatment for patients ...
Sarepta Therapeutics shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of U.S. shipments for its muscular gene therapy partially removes financial headwinds and ...
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