FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical ...

As drug costs rise and public trust falls, A.I. may transform the economics of clinical trials—and reshape the future of pharma. Unsplash+ Sixty percent of the total U.S. population takes at least one ...

A stylized image of Max Barnhart sitting on a chair with his arm on a pillow, receiving an IV infusion. The background is a grid containing a microscope image of malaria parasites flanked on each side ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...