To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 160 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 388 requests and issued 193, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately half of RMAT applications get approved (193 approvals / 388 applications = 49.7%).
