FDA accepts Bristol Myers NDA for mezigdomide in multiple myeloma, sets May 13, 2027 decision date - BMY News | RalliesFDA accepts Bristol Myers NDA for mezigdomide in multiple myeloma, sets May 13, 2027 decision date
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BMY• FDA accepts NDA and sets PDUFA date
- Bristol Myers Squibb secured FDA acceptance of its NDA for mezigdomide with carfilzomib, dexamethasone in relapsed or refractory multiple myeloma.
- The FDA set a PDUFA target action date of May 13, 2027.
- The filing was backed by Phase 3 SUCCESSOR-2 data showing median PFS of 18.0 months vs. 8.3 months; HR 0.48; p<0.0001.
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