The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration ...
Morrisville, North Carolina--(Newsfile Corp. - July 23, 2026) - iOrganBio is an innovator in intelligent cell manufacturing, redefining how human cells are engineered and produced at scale for ...
TUCSON, Ariz., and AMSTERDAM, May 19, 2026 — Critical Path Institute® (C-Path) today announced the launch of the New Approach Methodologies Developer Coalition (NAMs-DC), a precompetitive, ...
The past year has marked a turning point for New Approach Methodologies (NAMs) in preclinical drug development. No longer experimental curiosities, these human-relevant approaches have rapidly gained ...
On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...
The past year marked a proverbial inflection point for organoid models designed to uncover biological insights previously unattainable through traditional cell culture experiments or animal models.
Following the U.S. Food and Drug Administration's (FDA) April 2025 roadmap to reduce reliance on animal testing in preclinical safety studies, which stated that it would develop pathways for both ...
VivoSim Demonstrates Leadership in Field through AI-enabled NAMkind™ Liver and Intestine with High Accuracy Results, Including for Antibody Drug Conjugates (ADCs)SAN DIEGO, June 29, 2026 (GLOBE ...
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