In a university lab, an AI system generated millions of novel molecules to fight drug-resistant infections. And they're ...

Following Afghan shooting case, Trump administration launches rigorous audit of immigration status for residents from nations ...

The next critical steps in the USFDA process involve a rigorous on-site evaluation: "visiting manufacturing facilities, ...

A constitutional challenge can be criminal or civil. It can be brought against any government action or legislation. Among ...

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients ...

Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 ...

The prospect of diagnosing cancer through painless methods—such as a simple AI-assisted blood or urine test that detects tiny particles known as exosomes—is becoming increasingly realistic. Scientists ...

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

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

The Health Data, Technology, and Interoperability (HTI-4) Final Rule aims to strengthen the nation’s health IT ecosystem by ...