A team of scientists has uncovered the mechanism of cellular uptake for large and polar drugs and devised a novel strategy to ...

GenAI offers a realistic path forward in tackling previously undruggable targets, with the potential to reshape the entire ...

Andrei Georgescu of Vivodyne discusses key advantages of its humanized drug testing platform and the impact of the FDA’s policy shift.

The FDA is shifting towards a more human-relevant approach to drug testing, encouraging the use of New Approach Methodologies ...

Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced ...

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 ...

This is a groundbreaking step toward advancing public health by using more effective and human-relevant methods instead of ...

But this one, for Lilly’s first diabetes and weight-loss pill based on the GLP-1 hormone, was particularly fraught. Days ...

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