In a bold move, Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, has approved Sarepta Therapeutics' drug Elevidys for Duchenne muscular dystrophy, against the recommendations of his own staff. Despite a failed Phase 3 trial last year, Elevidys has been granted expanded approval to treat nearly all patients, regardless of age or wheelchair status. Documents reveal that Marks overruled three review teams and two top lieutenants who raised concerns about the drug's efficacy. This decision showcases the power of a single individual at the FDA to shape the future of drug approvals, raising questions about the agency's decision-making process and the influence of pharmaceutical companies. The approval of Elevidys marks the third time Sarepta has successfully convinced FDA officials to go against their staff's recommendations, highlighting the complexities and controversies surrounding drug approvals in the healthcare industry.