U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Relapsed or ...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application for iberdomide combined with Darzalex ...
The FDA has started a priority review of iberdomide as an add-on to Johnson & Johnson and Genmab's anti-CD38 antibody Darzalex (daratumumab) and dexamethasone, a standard regimen for relapsed or ...
Minimal residual disease (MRD) refers to the small number of myeloma cells that may remain after treatment and are not detectable using conventional response criteria. In multiple myeloma, MRD ...
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FDA Accepts BMY's NDA for Iberdomide Combo in Multiple Myeloma
Bristol Myers Squibb BMY announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate, iberdomide, in combination with standard therapies (daratumumab and ...
The NDA is supported by data from the EXCALIBER-RRMM trial, which evaluated the safety and efficacy of iberdomide, an investigational cereblon E3 ligase modulator.
The FDA accepted the new drug application for iberdomide based on minimal residual disease negativity benefit shown in the ...
Hepta refractory multiple myeloma is marked by antigen loss, genomic complexity, and 12.8 month median survival in multi centre data.
Bristol Myers Squibb said the U.S. Food and Drug Administration has granted priority review to its application seeking approval of its iberdomide drug candidate in certain patients with the blood ...
FDA has accepted the NDA for BMS's Iberdomide, an oral agent targetting relapsed/refractory multiple myeloma.
Princeton, New Jersey Thursday, February 19, 2026, 11:00 Hrs [IST] ...
Study expected to enroll 24 patients with the option to enroll an additional 45 patients at the recommended Phase 2 doseProtocol calls for three ...
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