On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”

The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals.

The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals.

“The impoverished laboratory environment in which mice and rats are maintained has been very good at increasing experimental replicability,” Steven Austad told the audience at the 12th Aging Research & Drug Discovery Meeting (ARDD) in Copenhagen last week. “But at the cost of sacrificing translational relevance.”

Acute respiratory distress syndrome (ARDS) is a life-threatening pulmonary condition marked by intense inflammation, alveolar damage and fluid accumulation in the lungs, often leading to respiratory failure. In a study recently published in Translational Research, researchers aimed to develop a more physiologically relevant model by combining two major ARDS contributors: gastric acid aspiration and ventilator-induced lung injury.

The lack of animal models that mimic human disease impedes the study of many pathologies that still lack treatment beyond symptom relief. This is what has happened so far with PURA syndrome, a rare disorder affecting brain development for which a mouse model has finally been developed. Other times, small and large models exist, but an effective treatment remains elusive, as is the case with Krabbe disease, a fatal disease in children that could be prevented with the advances in gene therapy.

The National Institutes of Health (NIH) is adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using alternative nonanimal research models aligns with the FDA’s recent initiative to reduce testing in animals.

In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.