Robust process development is essential in pharmaceutical manufacturing, optimizing drug discovery and ensuring regulatory compliance for high-quality outcomes.

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

The world of medicine has taken a significant leap forward with the first AI-generated drug entering clinical trials. This breakthrough has the potential to revolutionize drug discovery, transforming ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement ...

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.

In this study, I investigate the effects of commercialization costs on early- and late-stages of the innovation process in a quasi- experimental setting. Specifically, I leverage sudden policy shifts ...

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

Southwest Research Institute scientists developed a new purification technique to improve chromatography results without ...

Southwest Research Institute scientists developed a new purification technique to improve chromatography results without ...