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Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

Approval by European Commission would expand Reblozyl’s indication to include first-line treatment of anemia in adults with MDS in Europe In the pivotal Phase 3 COMMANDS study, Reblozyl nearly...
United States Anne Kerber Bristol Myers Squibb Exchange Commission European Union Head Of Late Clinical Development

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Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL) -January 30, 2024 at 07:00 am EST

U.S. FDA grants both FL and MCL applications Priority Review Applications based on results from TRANSCEND FL and TRANSCEND NHL 001, in which Breyanzi demonstrated clinically meaningful benefit with...
United States United Kingdom Bristol Myers Squibb Anne Kerber Exchange Commission Drug Administration

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

PRINCETON - Bristol Myers Squibb today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma for...
United States United Kingdom Great Britain Bristol Myers Squibb Anne Kerber Hemophagocytic Lymphohistiocytosis

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of The

At median follow-up of more than 30 months, Abecma maintained a 51% reduction in risk of disease progression or death with median PFS of 13.8 months compared with 4.4 months for standard regimensResponses were significantly improved with Abecma and continued to deepen over time with a complete response rate of 44% v...
United Kingdom United States Paula Rodriguez Otero Sergio Giralt Hemophagocytic Lymphohistiocytosis Bristol Myers Squibb

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