The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...

While significant progress has been made in developing treatments for rare diseases—highlighted by the approval of over 800 ...

By embracing a mix of co-innovation and best practices, stakeholders can boost productivity, streamline clinical trials, and ...

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

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

This new process for endocytic drugs represents a paradigm shift ... which his laboratory continues to explore. He said the ...

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

Scale-up is a common problem encountered in all forms of development across industries, and oral solid dose manufacturing ...

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

It is now possible to obtain three-dimensional, high-resolution images of enzyme activity in tissue samples or whole ...

Breakthrough research could make any IV drug able to be taken orally for a range of hard-to-treat cancers and other diseases, and redefine how medicines are designed, evaluated and delivered.

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