The FDA has launched an investigation into the recent death of an eight-year-old Brazilian boy who received Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, Elevidys, which has been connected to two other patient deaths this year. Sarepta and its partner Roche assert the death was unrelated to the treatment, with Roche highlighting the boy was not part of clinical trials. Following the FDA's probe, Elevidys shipments in the United States and several other countries, including those in the Gulf region, have been voluntarily paused. Additionally, the European Medicines Agency’s Committee recommended against approving Elevidys for certain pediatric groups, adding regulatory pressure on the therapy's future use.