Despite significant controversy, the FDA expanded approval for Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), based almost entirely on the decision of FDA Director Peter Marks. The therapy, which failed a Phase III clinical trial last year, gained initial approval for DMD patients ages 4 and 5 who can walk. The recent decision broadens access to patients of all ages, despite objections from FDA expert review teams. Critics, including former FDA officials, have raised concerns about the agency's apparent shift towards emotional rhetoric over scientific evidence. Review documents revealed internal dissent within the FDA, with statisticians, clinical teams, and directors questioning the therapy's effectiveness. Marks defended his decision based on secondary endpoints, overruling recommendations for additional studies. The controversial approval sets a precedent for future decision-making, raising doubts about the FDA's commitment to scientific standards and patient safety.