Sarepta Defies FDA Order to Halt Gene Therapy Shipments Amid Rising Patient Deaths
Sarepta Defies FDA Order to Halt Gene Therapy Shipments Amid Rising Patient Deaths Sarepta Therapeutics has publicly defied a rare request from the U.S. Food and Drug Administration (FDA) to immediately suspend all shipments of its gene therapy, Elevidys, following the confirmed death of a third patient. The biopharmaceutical company’s refusal marks a highly unusual standoff with the federal agency, intensifying scrutiny on its leading Duchenne muscular dystrophy treatment. The FDA disclosed late Friday that it had met with Sarepta…