Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging ...
Find out how NAMs are influencing safety assessments and decision-making in the pharmaceutical industry ahead of 2026.
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...
Although new approach methodologies (NAMs) are not that new, they remain a crucial and evolving aspect of the development and production of biopharmaceuticals. “NAMs have been around for 20 years plus ...
For more than 60 years, this blank slate approach has been the Food and Drug Administration’s gold standard — and for good ...
By leveraging LifeNet Health’s proprietary platform, Inotiv strengthens its commitment to new approach methodologies that advance human-relevant science, improve translational predictivity, and ...
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, ...
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 ...
Despite new methodologies and flexible regulatory pathways, CNS biopharmaceuticals still face significant safety assessment ...
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