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daratumumab

Marketing authorisation for Darzalex (daratumumab), from the Janssen Pharmaceutical Companies of Johnson & Johnson, to be used as a frontline treatment for newly diagnosed patients with multiple myeloma has been granted by the European Commission. more

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Janssen’s Darzalex (daratumumab) as a frontline treatment. more

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Following a planned review, the Data Monitoring Committee (DMC) has recommended termination of the Phase Ib/II study of daratumumab in combination with atezolizumab versus atezolizumab monotherapy in patients with previously treated NSCLC more

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Biotechnology company, Genmab, has announced that the FDA has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnos more

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Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

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The US FDA has granted 510(k) clearance for the Hydrashift 2/4 daratumumab assay from Sebia, which is intended for use with Hydragel IF for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. more

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The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics licence application (sBLA) for the use of daratumumab in front line multiple myeloma. more

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Genmab’s licensing partner, Janssen Biotech, has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in front line multiple myeloma. more

Technology

Genmab has announced that the FDA has approved the use of DARZALEX (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies. more

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Genmab has announced that its collaboration partner for daratumumab, Janssen Biotech, has decided to not initiate stage 2 of the Phase II study. more

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