WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...

The agency is proposing drugmakers use shorter nonrodent studies and other sources of evidence when developing monoclonal antibodies for non-cancer settings.

New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

Rick Pazdur had clashed with Trump officials on the legality and pace of their initiatives. He could still withdraw his ...

The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...

A multi-institute team led by St. Jude Children's Research Hospital and UT Southwestern Medical Center investigators ...

GE HealthCare (Nasdaq: GEHC) announced that it submitted its next-generation Signa Bolt MRI technology to the FDA for 510(k) ...

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the ...