BMY - Bristol Myers Squibb NDA And Other News: The Good Bad And Ugly Of Biopharma
Bristol Myers Squibb resubmits multiple myeloma therapy application
Bristol Myers Squibb (BMY) announced that it has resubmitted its application for ide-cel, a cell therapy targeting blood cancer multiple myeloma. The company had initially filed the application in May, but the FDA refused to review it and requested for details on manufacturing processes. Bristol Myers Squibb claims that it has fulfilled the requirement. However, the FDA has yet to respond to that.
The application has been backed by the results from the pivotal Phase 2 KarMMa study assessing the efficacy and safety of ide-cel