FDA broadens outlook with approval of umbilical cord blood April 18, 2023 - The FDA has approved Gamida Cell’s omidubicel-onlv (Omisirge) in patients over 12 years of age with blood cancers.
Omisirge is indicated for patients scheduled to undergo umbilical cord blood transplantation after myeloablative conditioning treatments such as chemotherapy or radiotherapy
Prior to its approval on Monday, the FDA had previously granted Omisirge breakthrough, priority review and orphan drug designations. Gamida is currently seeking out strategic partnerships to support Omisirge’s launch and commercialization.
https://www.biospace.com/article/fda-approves-gamida-s-blood-cancer-cell-therapy/