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The European Medicines Agency's CHMP recommended approval for Bristol Myers Squibb's anemia drug Reblozyl for transfusion-dependent anemia in adults with MDS.
Bristol Myers Squibb received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its anemia drug Reblozyl (luspatercept) as a treatment for adults with transfusion-dependent anemia due to very low, low, and intermediate-risk myelodysplastic syndromes (MDS).
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
If approved, this would be the fourth authorized indication for Reblozyl in the EU.
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El CHMP de la Agencia Europea de Medicamentos recomendó la aprobación del medicamento para la anemia Reblozyl de Bristol Myers Squibb para la anemia dependiente de transfusiones en adultos con SMD.