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 ...

The drug development process faces challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical ...

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 ...

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...

Funding and clinical trial-based barriers must be addressed to ensure success on the path to developing a DMT for Parkinson’s.

Karan Arora, senior vice president of advanced assays, AI, and pharma services at Leica Biosystems outlines the critical role diagnostics have to play in unlocking the promise of precision medicine.

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.

Kivo reports that the journey of prescription drugs involves extensive research, clinical trials, regulatory reviews, and ...