Surge in RMAT designations awarded by the FDA - Pharmaceutical Technology

The number of RMAT designations awarded by the FDA increased sharply from 2024, reaching a record of 48 RMAT designations in 2025. The number of RMAT designations awarded by the FDA increased sharply from 2024, reaching a record of 48 RMAT designations in 2025. The FDA first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017. Credit: Tada Images / Shutterstock.com Since the first time the US Food and Drug Administration (FDA) awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023. The number of RMAT designations awarded by the…

Source: Pharmaceutical Technology