The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, science-forward drug development. By reducing reliance on animal models and ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a major policy shift to reduce reliance on animal testing in the evaluation of monoclonal antibodies and other drugs. The ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

The FDA will begin replacing animal testing in the development of monoclonal antibody therapies and other drugs with human-based methods. The agency said the new approach will aim to improve drug ...

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions ...

The FDA's shift towards an evidence-based approach in the coadministration of vaccines for respiratory viruses like COVID-19, flu, and RSV is stirring significant debate. Under the guidance of Vinay ...

Stem Pharm, a Madison biotech startup, is using lab-created 3D "organoids" to develop a treatment for Alzheimer's disease. In April, the FDA and NIH announced plans to incentivize so-called "new ...

Modeling and simulation will be a key component for shift to non-animal methodologies Introducing NAMVantage(TM), a flagship package offering PBPK and QSP professional services and regulatory strategy ...

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) DiNABIOS Applauds Historic U.S. Senate Passage of FDA ...