A source familiar with the decision says President Donald Trump is expected to nominate Heidi Overton to lead the FDA. If confirmed, the nomination would set the agenda for agency priorities across approvals, enforcement, and how emerging technologies and therapeutic categories are evaluated. For biotech, the near-term implication is not only leadership continuity but the likelihood of shifting emphasis on regulatory timelines, platform evaluation strategies, and safety/benefit frameworks for novel modalities. Companies awaiting decisions or building submission plans will now watch how Overton’s policy stance influences guidance and review posture.