U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
FDA Declines Review of Bristol Myers Squibb and bluebird’s Multiple Myeloma Therapy
B-cell maturation antigen (BCMA), Biologics License Application (BLA), Business, CAR-T Therapy, Collaborations, FDA, FDA/Regulatory, Immunotherapies, Investors, Refusal to File letter, Relapse/Refractory Multiple Myeloma, Shareholders, SharesShares of bluebird bio were down in trading after the U.S. Food and Drug Administration declined to review a Biologics License Application for the experimental CAR-T treatment idecabtagene vicleucel for multiple myeloma co-developed with Bristol Myers Squibb.
The FDA refused to fully review the marketing application for Zogenix’s treatment for seizures associated with Dravet syndrome.