Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

As a descendant of an Indigenous Amazonian tribe, Maria Astolfi was concerned about research she conducted as a graduate ...

By granting creators and inventors exclusive rights to their work, IP laws provide a powerful incentive for individuals and ...

Neurological disorders, including Alzheimer’s, Parkinson’s, ALS, and multiple sclerosis, pose significant challenges due to their complex pathophysiology ...

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

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

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

The U.S. Food and Drug Administration announced earlier this month that it will be phasing out animal testing for some new ...

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

Besides generics, Dr. Reddy’s has committed a lot of resources to develop its biosimilars as well as new chemical entity business. Biosimilars have been seen as a growth engine for large, capable ...

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

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