Regulatory Reckoning: Gene-Editing Tragedy, FDA Rejections, and the Squeeze on New Drugs

A six-year-old girl's death after receiving an experimental gene-editing therapy in China has triggered alarm bells across the global biotech industry. The tragedy, detailed in a joint investigation by Retraction Watch and Science, reveals "serious failures in risk assessment, transparency and institutional oversight" according to scientists. The case involves a bespoke therapy designed to correct a neurodevelopmental genetic mutation administered in March 2025, now raising...