Day: March 20, 2025

For more than four decades, government grants have been a cornerstone of early-stage drug development, providing crucial non-dilutive funding that has fueled tens of thousands of programs. They’ve been vital in translating innovative scientific discoveries into life-saving therapies. However, the current political climate introduces an element of uncertainty regarding the future availability and consistency of … Read more

The FDA released a user guide, the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) based on case studies highlighting key concepts and regulatory considerations crucial for successful rare disease drug development programs. The case studies present successful approaches used by sponsors in designing and conducting their rare disease drug … Read more