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Janssen files submission for subcutaneous Darzalex in Europe pharmaceutical-technology
July 23, 2019
Janssen Pharmaceutical has submitted an application to the European Medicines Agency (EMA) seeking approval for subcutaneous formulation of Darzalex (daratumumab) to treat multiple myeloma.
The Seventh HIMSS-Elsevier Digital Healthcare Award in APAC Opens for submission biospectrumasia
May 13, 2019
Since 2013, the HIMSS-Elsevier Digital Healthcare Award has attracted 218 submissions from 120 organizations across 30 countries, impacting over 41 million patients worldwide
Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma firstwordpharma
January 09, 2019
"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
Takeda gets positive CHMP opinion for ALUNBRIG biospectrumasia
September 29, 2018
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...