Biochemical Engineering

FDFDA imposes holds on 3 CARsgen cell therapies after inspecting facility

FDFDA imposes holds on 3 CARsgen cell therapies after inspecting facility

13th December 2023

The FDA has put three CAR-T cell therapy candidates from CARsgen Therapeutics on clinical hold after paying a visit to its manufacturing facility. CARsgen started clinical manufacturing at the North Carolina facility early last year and released its first batch 15 months ago, but the FDA reset the narrative this week by putting three CAR-Ts on hold until the findings of its inspection of the facility are resolved. Source: Fierce Biotech 13/12/2023


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