CRLs submitted to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071
“CARsgen Therapeutics announces that the U.S. Food and Drug Administration (“FDA”) recently did a follow-up inspection of the manufacturing site located in Durham, North Carolina. The inspection was positive, and no observation (Form 483) was issued. The Company has submitted the complete response letters to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071 to FDA on October 4, 2024. FDA is expected to respond within 30 calendar days.”
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