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

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

24.12.2025 / 12:58 CET/CEST


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, a global leader in human‑centric New Approach Methodologies (NAMs) for preclinical research, today celebrates the U.S. Senate’s passage of the FDA Modernization Act 3.0 (FDAMA 3.0), a milestone in modernizing drug development by enabling advanced, human‑relevant nonclinical testing methods.

The Act builds on prior modernization efforts by directing the U.S. Food and Drug Administration (FDA) to establish clear qualification pathways for NAMs, including advanced cell-based, microphysiological and in silico systems. Together, these approaches promise improved predictivity, shorter development timelines, and a meaningful reduction in animal testing.

“FDA Modernization Act 3.0 signals a transformative moment for science and industry,” said Dr. Alexandra Rhoden, CEO of DiNABIOS. “Regulatory alignment creates opportunity, but adoption will ultimately be driven by scientific rigor, reproducibility and human relevance,  areas where DiNABIOS has made sustained investments.”

Dr. Marcel Grunert, COO of DiNABIOS, added: “This legislation validates the industry’s shift toward scalable, decision-ready NAM platforms. DiNABIOS is well positioned to support pharmaceutical partners as these methods move into core decision‑making workflows.”

Reto Wittwer, Chairman of DiNABIOS, commented: “Modernizing regulatory frameworks is essential for innovation, efficiency and ethical responsibility. This moment underscores the importance of companies that combine scientific excellence with operational readiness - exactly what DiNABIOS represents.”

 

About DiNABIOS

DiNABIOS is an innovative life science company improving the predictivity and efficiency of preclinical research from lab to life by integrating advanced experimental and computational systems grounded in human cell and tissue biology. For more information visit www.dinabios.com.

 

Contact
DiNABIOS AG
Wagistrasse 25
8952 Schlieren (Zurich)
Switzerland
contact@dinabios.com


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File: Media Release DiNABIOS_FDA Modernization Act_2025


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2251462  24.12.2025 CET/CEST

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