1. Pink Sheet

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 
• By Bridget Silverman

The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.

The FDA's regenerative medicine advanced therapy (RMAT) designation helps cultivate the next crop of biologic therapies. (Shutterstock)
Key Takeaways
  • In FY 2024 and the first quarter of FY 2025, the Center for Biologics Evaluation and Research received one quarter of all RMAT requests and made 34% of all RMAT grants through the life of the program.
  • Approved RMATs jumped from a previous high of 51% of requests to 73% in FY 2024.
  • Four RMAT-designated BLAs are currently under FDA review.

One-third of all the regenerative medicine advanced therapy (RMAT) designations granted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research were awarded in fiscal years 2024...

The updates, which include data through 31 December 2024, are the first items posted by CBER since the Trump Administration’s communication freeze was implemented on 21...

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