FDA-awarded RMAT designations continue to surge in 2025

8 July 2026

Since the US Food and Drug Administration (FDA) first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023.

However, the number of RMAT designations increased sharply in 2024, reaching a record of 48 RMAT designations in 2025, reflecting the expanding regenerative medicine landscape and suggesting that a larger number of these therapies are progressing towards regulatory review, according to pharma intelligence firm GlobalData.

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