DATA GRAPHICS | Data Byte
FDA, EMA make similar decisions on cell and gene therapies
EMA has grant more expedited approvals than FDA, but regional differences in available therapies mostly due to where the candidates were submitted
November 20, 2023 11:27 PM UTC
Since 2016, half of the 23 cell and gene therapies approved in the U.S. or Europe won approval in both territories. The remainder are evenly split, with six approved in the EU only and five in the U.S. only.
All five of the U.S.-only approvals have come in the past year, so those products could still be approved in the EU, although none were under review as of Nov. 7. ...