COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that it has held a successful pre-Biologics License Application (pre-BLA) meeting for Prochymal used in the treatment of graft-versus-host disease (GvHD). A BLA is a comprehensive regulatory submission prepared by a biologic drug’s sponsor to obtain full marketing approval from the Food and Drug Administration (FDA). As an outcome of the meeting between Osiris and FDA, the parties finalized the content and timing of what is expected to be the first BLA submission for a stem cell product.
