The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the impact of mass layoffs at the FDA, impact on ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to develop life-saving medicines.

The FDA is phasing out animal testing and moving to more human-relevant methods. This was announced as one of Marty Makary’s ...

Survey results revealed a widespread - and often misguided - belief that subcutaneous delivery volumes must be limited to 3 ...

Explore the impact of 3D models in drug discovery and how they enhance predictive insights in pre-clinical research.

In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according to an exclusive report from The Wall Street Journal ...

With the FDA's push to adopt and validate New Approach Methodologies (NAMs) under the FDA Modernization Act 2.0, Spanios and ...

Introducing our In Focus on organ-on-a-chip (OoC) technology in drug development, this video explores what OoCs are, how they ...

An editorial published in Brain Medicine reveals that many widely prescribed medications may disrupt sterol biosynthesis—an ...

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...