The biotech regulatory environment experiences turbulence with leadership shifts and controversial AI adoption. The recent FDA departure of Vinayak Prasad, center for biologics evaluation and research director, follows criticism over regulatory approaches and impacts companies like Sarepta and Capricor. Concurrently, deployment of FDA's AI tool Elsa reveals risks of fabricated studies, launching debate on data integrity in drug approvals. These events coincide with a cautious industry outlook shaped by shifting regulatory processes, influencing stock performance and strategic planning.