Approved Cellular and Gene Therapy Products | FDA

Below is a list of licensed products from the Office of Therapeutic Products (OTP).Approved ProductsProduct & Trade NameManufacturerABECMA (idecabtagene vicleucel)Celgene Corporation, a Bristol-Myers Squibb CompanyADSTILADRIN (nadofaragene firadenovec-vcng)Ferring Pharmaceuticals A/SALLOCORD (HPC, Cord Blood)SSM Cardinal Glennon Children's Medical CenterAMTAGVI (lifileucel)Iovance Biotherapeutics, Inc.AUCATZYL (obecabtagene autoleucel)Autolus LimitedBEQVEZ (fidanacogene elaparvovec-dzkt)Pfizer, Inc.BREYANZI (lisocabtagene maraleucel)Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyCARVYKTI (ciltacabtagene autoleucel)Janssen Biotech, Inc.CASGEVY (exagamglogene autotemcel [exa-cel])Vertex Pharmaceuticals IncorporatedCLEVECORD (HPC Cord Blood)Cleveland Cord Blood CenterDucord, HPC Cord BloodDuke University School of MedicineELEVIDYS (delandistrogene moxeparvovec-rokl)Sarapeta Therapeutics, Inc.ENCELTO (revakinagene taroretcel-lwey)Neurotech Pharmaceuticals, Inc.GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)Organogenesis IncorporatedHEMACORD (HPC, cord blood)New York Blood CenterHEMGENIX (etranacogene dezaparvovec-drlb)CSL Behring LLCHPC, Cord BloodClinimmune Labs, University of Colorado Cord Blood BankHPC, Cord Blood - MD Anderson Cord Blood BankMD Anderson Cord Blood BankHPC, Cord Blood - LifeSouthLifeSouth Community Blood Centers, Inc.HPC, Cord Blood - BloodworksBloodworksIMLYGIC (talimogene laherparepvec)BioVex, Inc., a subsidiary of Amgen Inc.ITVISMA (onasemnogene abeparvovec-brve)Novartis Gene Therapies, Inc.KEBILIDI (eladocagene exuparvovec-tneq)PTC TherapeuticsKYMRIAH (tisagenlecleucel)Novartis Pharmaceuticals CorporationLANTIDRA (donislecel)CellTrans Inc.LAVIV (Azficel-T)Fibrocell TechnologiesLENMELDY (atidarsagene autotemcel)Orchard Therapeutics (Europe) LimitedLUXTURNA (voretigene neparvovec-rzyl)Spark Therapeutics, Inc.LYFGENIA (lovotibeglogene autotemcel [lovo-cel])bluebird bio, Inc.MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)Vericel Corp.OMISIRGE (omidubicel-onlv)Gamida Cell Ltd.PAPZIMEOS (zopapogene imadenovec-drba)Precigen, Inc.PROVENGE (sipuleucel-T)Dendreon Corp.REGENECYTE (HPC, Cord Blood)StemCyte, Inc.RETHYMIC (allogeneic processed thymus tissue – agdc)Enzyvant Therapeutics GmbHROCTAVIAN (valoctocogene roxaparvovec-rvox)BioMarin Pharmaceutical IncRYONCIL (remestemcel-L-rknd) Mesoblast, Inc.SYMVESS (acellular tissue engineered vessel-tyod) Humacyte Global, Inc.SKYSONA (elivaldogene autotemcel)bluebird bio, Inc.STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)Stratatech CorporationTECARTUS (brexucabtagene autoleucel)Kite Pharma, Inc.TECELRA (afamitresgene autoleucel)Adaptimmune LLCVYJUVEK (beremagene geperpavec-svdt)Krystal Biotech, Inc.YESCARTA (axicabtagene ciloleucel)Kite Pharma, IncorporatedZEVASKYN (prademagene zamikeracel)Abeona Therapeutics, Inc.ZYNTEGLO (betibeglogene autotemcel)bluebird bio, Inc.ZOLGENSMA (onasemnogene abeparvovec-xioi)Novartis Gene Therapies, Inc.