FDA Announcement
April 10, 2025 — FDA Redefines Preclinical Standards
FDA encourages the replacement of animal models with organoid and AI systems.
— Dr. Makary, FDA Commissioner
With over 90% of drugs failing in clinical trials, the time to modernize preclinical models is now.
At Cypre, we commend the FDA and the US Government for their leadership through the Modernization Act 2.0 and are proud to support this shift with our immune-integrated organoid platform.