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 initiatives fail, ...

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 U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Synthetic” and “natural” are largely useless terms. But not “semisynthetic.” It’s a real word that describes a critical ...

Organoids are miniature tissue or organ models formed by stem cells (including pluripotent stem cells, tissue-specific adult ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

The goal of this collaborative was to examine the contributing factors towards the failure of late-stage clinical product development and develop key considerations for stakeholders to improve the ...

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors and the general public. “Artificial intelligence ...