The FDA faces notable leadership turnover including the scheduled retirement of Jacqueline Corrigan-Curay, acting head of the Center for Drug Evaluation and Research, amid broader agency restructuring. FDA scrutiny extends to novel trial practices, such as halting clinical studies transferring US patient cells abroad for gene editing. In the governance arena, the Association for Molecular Pathology announced election results elevating new leadership poised to guide molecular diagnostics innovation. Convergences between regulation, industry, and policy emerged at BIO 2025, where key voices called for enhanced global collaboration and regulatory agility to sustain innovation momentum in life sciences.