Day: September 25, 2025

Regenerative medicine therapies, such as stem cell therapies, have the potential to transform the future of healthcare, but navigating the FDA approval process can seem daunting. A new FDA Guidance Document repackages established expedited programs to describe a path to faster approval of regenerative therapies by the FDA. The guidance reaffirms that while stem cell … Read more

Cell and gene therapies (CGTs) are revolutionizing treatment for patients, particularly for those with rare and life-threatening diseases. Yet, the path from development to approval is challenging because rare disease clinical trials often involve very small patient populations and pose unique logistical challenges. This week, two FDA guidance documents outline how available innovative trial designs … Read more