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 collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...

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 ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most challenging aspect of drug development -- finding new molecules that lead to ...

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 ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

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 ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...