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CAR T cell therapy

PharmaDeviceNews CAR T cell therapy
Cellares FDA PreCheck selection puts automated cell therapy manufacturing under early review
Pharma & Biotech

Cellares enters FDA PreCheck as Cell Shuttle moves from automation promise to regulatory proof

Find out how Cellares’ FDA PreCheck selection could reshape automated cell therapy manufacturing while leaving product approval risks intact.

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Representative image: Illustration depicting CAR T-cell therapy research in the central nervous system, reflecting the FDA’s removal of Yescarta’s CNS limitation for relapsed or refractory primary CNS lymphoma.
Pharma & Biotech

FDA removes CNS limitation for Yescarta, reshaping the regulatory boundary for CAR T therapy in primary CNS lymphoma

Kite Pharma, a subsidiary of Gilead Sciences, has received approval from the U.S. Food and Drug Administration to update the prescribing information for Yescarta axicabtagene ciloleucel by removing the prior limitation of use in patients with relapsed or refractory primary central nervous system lymphoma. The decision follows safety findings from an investigator sponsored Phase 1

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