Healio

FDA efforts to reduce animal testing signal shift toward AI, organ-on-chip study methods

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 ...
Opinion
HealioOpinion

Editorial: Why the FDA’s move away from animal testing is scientifically necessary

The FDA’s recent announcement to reduce, and in some cases replace, animal testing for monoclonal antibodies and other therapeutics represents one of the most consequential regulatory developments in ...
Medical Xpress

New paper urges caution as FDA plans to phase out animal testing in drug development

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 ...
News Medical

How new approach methodologies and regulation are shaping safer, more predictive therapeutics outcomes

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, ...
JD Supra

FDA Publishes New Draft Guidance on Reducing Animal Testing in Nonclinical Safety Studies

The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent ...
Undark Magazine

Why the FDA Is Embracing Old Math for New Drugs

In the 20th-century statistics wars, Bayesians were underdogs. Now their methods may help speed treatments to market.
Yahoo

New FDA guidance that’s a ‘huge deal’ for clinical trials

Add Yahoo as a preferred source to see more of our stories on Google. FDA headquarters in White Oak, Maryland (Sarah Silbiger via Getty Images) This story was originally published on PharmaVoice. To ...
Benzinga.com

DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs)

DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs) ZURICH/SCHLIEREN, Switzerland, December 24, 2025 – DiNABIOS AG, ...
Seeking Alpha

Inotiv Leverages LifeNet Health Proprietary Platform to Advance New Approach Methodologies in Translational Drug Discovery

WEST LAFAYETTE, Ind., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Inotiv, Inc. (NOTV) (the “Company”, or “Inotiv”), a leading Contract Research Organization specializing in nonclinical and analytical drug ...
BioTechniques

A new approach to drug development with unexplored peptides

Targeted modulation of certain intracellular signaling proteins could represent an exciting new approach to drug development.
EurekAlert!

New paper urges caution as FDA plans to phase out animal testing in drug development

Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately backfire and raise safety and effectiveness concerns, says Sara Gerke, the ...