Pharmaceutical Executive Pharmaceutical Executive Daily: FDA's Agentic AI Deployment
Dec 3, 2025
Regeneron and Tessera are shaking up the biotech scene with a massive $150 million gene editing collaboration focused on RNA-based platforms. Meanwhile, the FDA is rolling out transformative agentic AI tools to streamline operations across the agency. In a surprising twist, Richard Pazdur is reportedly stepping down as director of CDER, raising questions about the future of this pivotal role. Tune in for an insightful dive into these game-changing developments in the pharmaceutical industry!
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Regeneron Teams Up For Gene Writing
- Regeneron launched a $150 million collaboration with Tessera to advance next-generation gene editing.
- The partnership pairs Regeneron's development strength with Tessera's RNA-based gene writing platform.
FDA-wide Agentic AI Rollout
- The FDA is deploying agentic AI across the agency to streamline workflows and analyze complex data faster.
- The move aims to strengthen review consistency and modernize internal operations for emerging technologies.
AI Aims To Modernize FDA Reviews
- The FDA expects agentic AI to improve review consistency and better position the agency for new technologies.
- Officials view the deployment as modernization to handle increasingly complex datasets and reviews.