Nearly seven years after the FDA approved Novo Nordisk’s Ozempic for diabetes treatment, this medication and other GLP-1 receptor agonists have proven very effective in promoting weight loss. For the ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

Bari Kowal, Senior Vice President, Development Operations & Portfolio Management at Regeneron Clinical trial innovation is a hot topic, but it’s not a new one. The first fully virtual randomized trial ...

Discover why biomarkers are critical in modern drug discovery and clinical trials, enabling better target validation.

Researchers have developed a human intestinal cell model that closely mimics the structure and function of the human gut, enabling more precise prediction of drug-induced gastrointestinal toxicity ...

Mayo Clinic, for its part, described the collaboration as its first strategic partnership of this scale with a global biopharmaceutical company, signaling a growing role for platform-based approaches ...

The Food and Drug Administration (FDA) has issued a new guidance document entitled “Enhancing Participation in Clinical Trials – Eligibility Criteria, Enrollment Practices, and Trial Decision.” The ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Ratain is the Leon O. Jacobson professor of medicine and the director of the Center for Personalized Therapeutics at the University of Chicago, and chairman of the board of the Optimal Cancer Care ...