U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
Shares 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.
Here is a look at BioSpace’s top 10 stories of 2018.
Innocoll received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.