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 ...
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 ...
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.
Fierce Biotech

FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
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FDA Publishes New Draft Guidance on Reducing Animal Testing in Nonclinical Safety Studies

The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent ...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

3 key takeaways from the FDA’s new animal testing guidance

Add Yahoo as a preferred source to see more of our stories on Google. This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice ...
BioTechniques

Infographic: Integrating new approach methodologies into your therapeutics development research

New approach methodologies (NAMs) – such as organoids, spheroids and microfluidic chip systems – aim to streamline early-stage drug discovery and revolutionize preclinical testing by augmenting ...
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, ...
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 ...
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 ...
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 ...