The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

Barbara Slusher explains the hit-to-lead optimization process, high-throughput screening, and the role of AI and organoids in ...

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 laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal ...

From survivorship bias to root causes! Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening ...

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 ...

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 ...

This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion. The ...

Researchers at Kent have established a computational protocol that could accelerate the development of more effective ...

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 ...

Business leaders must understand what patient-centric care really requires. Too often, patients, researchers and investors ...

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 ...