Bristol Myers Squibb (BMS) and bluebird bio, Inc have announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for…

  The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the drug daratumumab (Darzalex®, commercialised by…

  European Commission (EC) has approved elotuzumab  –marketed under the brand Empliciti by Bristol-Myers Squibb (BMS)– plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who…

The pharmaceutical company Janssen, who produce a range of myeloma medicines, have today announced their application to the European Medicines Agency (EMA) for a license extension for daratumumab. This license extension, if approved by the…