The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

Officials with the FDA have released a draft guidance that aims to help drug developers validate new approach methodologies (NAMs) that can be used in place of animal testing. Based on human-centric ...

The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug developmen ...

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...

The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...

Non-animal testing methods could save drugmakers time and money, officials say ...

WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, ...

In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches. One year later, much speculation ...

FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...

As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of cheaper, safer pharmaceuticals as well as alleviating animal suffering. But ...