Bristol-Myers Squibb (BMY +2.2%) and collaboration partner Acceleron Pharma (XLRN -1.3%) announce that, following a meeting with the FDA two days ago, there will be no advisory committee review of Celgene’s marketing application seeking approval of Reblozyl (luspatercept-aamt) for the treatment of adult patients with very low-to-intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell transfusions. The review was scheduled for Wednesday, December 18.
The agency’s April 4, 2020 action date remains as is.
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