The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...

After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...

Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...

Drug pricing is influenced by numerous factors, but technology has the potential to strike the critical balance between ...

With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors ...

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

Researchers at the University of Oklahoma have developed a breakthrough method of adding a single nitrogen atom to molecules, ...

The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for ...