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 ...

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

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 subjectivity into what should be an objective process.

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, ...

The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent ...

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 ...

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Using traditional animal models, drug development can take 10–15 years and cost more than US$2 billion per approved drug, with over 90% of drugs that succeed in animal tests failing in human trials.

IQVIA Holdings Inc. ("IQVIA") (NYSE: IQV), a leading global provider of advanced analytics, technology solutions and clinical ...

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 ...