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

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 […]

Genentech’s fenebrutinib challenges the PPMS treatment ceiling but does not yet reset it

Genentech’s fenebrutinib challenges the PPMS treatment ceiling but does not yet reset it

Genentech has reported late-breaking Phase III data from the FENtrepid trial showing that its investigational Bruton’s tyrosine kinase inhibitor fenebrutinib achieved non-inferiority to ocrelizumab in reducing disability progression in patients with primary progressive multiple sclerosis. The results were presented at the ACTRIMS Forum 2026 and position fenebrutinib as the first oral, brain-penetrant therapy to directly […]

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