Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research Collaborations

Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus" or the "Company"), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced ...
EurekAlert!Opinion

New paper urges caution as FDA plans to phase out animal testing in drug development

Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately ...
News Medical

How new approach methodologies and regulation are shaping safer, more predictive therapeutics outcomes

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, ...
JD Supra

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
GEN

The Newest New Approach Methodologies

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 ...
Benzinga.com

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

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, ...
Yahoo

3 key takeaways from the FDA’s new animal testing guidance

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 ...
BioTechniques

Infographic: Integrating new approach methodologies into your therapeutics development research

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 ...
JD Supra

FDA updates compliance program inspection manual for the QMSR age

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
BioSpaceOpinion

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging ...
BioProcess International

Regulatory Frameworks for Central Nervous System Safety Assessment: Bridging Traditional Methods and New Modalities

Despite new methodologies and flexible regulatory pathways, CNS biopharmaceuticals still face significant safety assessment ...

VivoSim Expands Asia-Pacific Access to NAMKind™ Human-Based Toxicology Services Through New Distributor Agreement in Korea and China

With distribution agreements with JCBio and Tekon Biotech in place, NAMKind™ liver and small intestine toxicology services are now available via local distributor engagement across Korea and China, ...