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Janssen Pharmaceutical has submitted an application to the European Medicines Agency (EMA) seeking approval for subcutaneous formulation of Darzalex (daratumumab) to treat multiple myeloma.
Since 2013, the HIMSS-Elsevier Digital Healthcare Award has attracted 218 submissions from 120 organizations across 30 countries, impacting over 41 million patients worldwide
"The MAA submission for selinexor is an important milestone for Karyopharm and the CHMP's granting of accelerated assessment further underscores the urgent need to improve outcomes for patients with highly refractory multiple myeloma," said Sharon Shacham
As part of this submission, the CHMP also reviewed data from the first interim analysis of the Phase 3 ALTA-1L trial, which met its primary endpoint...