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, ...
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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
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 ...
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 ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
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 ...
Draper recently received an up to $26.7 million other transaction award (OTA) from the Advanced Research Projects Agency for Health (ARPA-H). The award supports the agency's Computational ADME-Tox and ...
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 ...
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 ...
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 ...
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