Humacyl regulatory update

Humacyte said FDA granted regenerative medicine advanced therapy (RMAT) designation to Humacyl for vascular access in hemodialysis patients. The designation, created via the 21st Century Cures Act, provides the same expedited development and regulatory review actions afforded products that receive FDA’s breakthrough therapy designation. The product consists of decellularized bioengineered blood vessels and has Fast Track designation from FDA...