In April 2025, the U.S. Food and Drug Administration (FDA) announced a significant transition away from traditional animal testing in drug development. The agency introduced New Approach Methodologies (NAMs), including artificial intelligence-based models and laboratory-engineered human organ-like structures, to enhance drug safety, reduce research and development costs, and minimize animal use. A pilot program will allow selected developers to test antibody-based drugs using NAMs, marking a transformative change in drug evaluation practices
