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BMS' Breyanzi CAR-T Therapy Approved for Treating Mantle Cell Lymphoma | iPharmaCenter
Bristol Myers Squibb (BMS) has received European Commission approval to extend the use of its CAR T cell therapy Breyanzi (lisocabtagene maraleucel, liso-cel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). This approval covers patients who have previously undergone at least two systemic treatments, including a Bruton’s tyrosine kinase (BTK) inhibitor. The positive decision is founded on data from the TRANSCEND NHL 001 trial, where Breyanzi showed a
ipharmaservices
Nov 25
Novartis Receives FDA Approval for Itvisma, Expanding Access to Gene Replacement Therapy for People of All Ages Living with Spinal Muscular Atrophy (SMA)
East Hanover, N.J., [November 24, 2025] - Novartis announced today that the U.S. Food and Drug Administration (FDA) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, as well as adolescents and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene. This approval makes Itvisma the first and only gene replacement therapy available for this broad population of people a
ipharmaservices
Nov 25
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