FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Iberdomide has the potential to be the first approved CELMoD agent
Iberdomide has the potential to be the first approved CELMoD agent
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
The approval is backed by data showing deep, durable responses and manageable tolerability
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The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
Pembrolizumab has shown meaningful benefit only when combined with chemotherapy
Singh previously served as Head of IT (Development and Manufacturing Services) at Syngene International Limited, Lead of IT Manufacturing at UPL, and AGM at The Hi-Tech Gears
The study will run across 18 sites and enroll roughly 200 patients over 24 months
The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38
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