Source: Flickr user e-Magine Art. As of this writing, there are more than 181,200 ongoing clinical studies throughout the United States and around the globe per the U.S. National Institutes of Health.

The process of drug development can lengthy and complex, with multiple stages and regulatory requirements to be met. In the United States, the Food and Drug Administration (FDA) is responsible for ...

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, ...

Patient-centric evidence, such as PROs and RWE, offers insights into patients' needs, enhancing drug development beyond traditional endpoints. Challenges include increased complexity and regulatory ...

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 ...

A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the ...

Partnership combines AI-powered protein manufacturing with advanced drug delivery technologies to accelerate timelines and improve therapeutic outcomes. Through this collaboration, Axio BioPharma will ...

Drug development pipelines are the lifeblood of the pharmaceutical industry. It is crucial for investors to understand milestones like FDA approvals and the impact of losing exclusivity on profits to ...