FDA quickly follows a voluntary pause for CAR-T 2.0 with a clinical hold to investigate 2 patient deaths
Celyad’s voluntary pause didn’t last long.
The biotech put out word after the market closed Monday that the FDA has swiftly followed up the news of 2 patient deaths and an announced pause with a clinical hold, shifting control over the trial halt to federal regulators.
According to the Belgian biotech $CYAD, the agency decided on the hold “due to insufficient information to assess risk to study subjects.”
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