Below is a list of licensed products from the Office of Therapeutic Products (OTP).
With the rapid development of the cell and eco-friendly packaging (CGT) industry, the FDA has approved a number of revolutionary products, bringing new hope to intractable diseases such as cancer and genetic diseases. As of May 15, 2025,FDA Approved Cell and Gene Therapy Products, the world's approved CGT products include CAR-T cell therapy, gene modification therapy, such as KYMRIAH®, ZOLGENSMA® and more than 40 other products.
Below is a list of licensed products from the Office of Therapeutic Products (OTP).
| NO. | Product & Trade Name | Manufacturer |
| 1 | ABECMA (idecabtagene vicleucel) | Celgene Corporation, a Bristol-Myers Squibb Company |
| 2 | ADSTILADRIN (nadofaragene firadenovec-vcng) | Ferring Pharmaceuticals A/S |
| 3 | ALLOCORD (HPC, Cord Blood) | SSM Cardinal Glennon Children's Medical Center |
| 4 | AMTAGVI (lifileucel) | Iovance Biotherapeutics, Inc. |
| 5 | AUCATZYL (obecabtagene autoleucel) | Autolus Limited |
| 6 | BEQVEZ (fidanacogene elaparvovec-dzkt) | Pfizer, Inc. |
| 7 | BREYANZI (lisocabtagene maraleucel) | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
| 8 | CARVYKTI (ciltacabtagene autoleucel) | Janssen Biotech, Inc. |
| 9 | CASGEVY (exagamglogene autotemcel [exa-cel]) | Vertex Pharmaceuticals Incorporated |
| 10 | CLEVECORD (HPC Cord Blood) | Cleveland Cord Blood Center |
| 11 | Ducord, HPC Cord Blood | Duke University School of Medicine |
| 12 | ELEVIDYS (delandistrogene moxeparvovec-rokl) | Sarapeta Therapeutics, Inc. |
| 13 | ENCELTO (revakinagene taroretcel-lwey) | Neurotech Pharmaceuticals, Inc. |
| 14 | GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) | Organogenesis Incorporated |
| 15 | HEMACORD (HPC, cord blood) | New York Blood Center |
| 16 | HEMGENIX (etranacogene dezaparvovec-drlb) | CSL Behring LLC |
| 17 | HPC, Cord Blood | Clinimmune Labs, University of Colorado Cord Blood Bank |
| 18 | HPC, Cord Blood - MD Anderson Cord Blood Bank | MD Anderson Cord Blood Bank |
| 19 | HPC, Cord Blood - LifeSouth | LifeSouth Community Blood Centers, Inc. |
| 20 | HPC, Cord Blood - Bloodworks | Bloodworks |
| 21 | IMLYGIC (talimogene laherparepvec) | BioVex, Inc., a subsidiary of Amgen Inc. |
| 22 | KEBILIDI (eladocagene exuparvovec-tneq) | PTC Therapeutics |
| 23 | KYMRIAH (tisagenlecleucel) | Novartis Pharmaceuticals Corporation |
| 24 | LANTIDRA (donislecel) | CellTrans Inc. |
| 25 | LAVIV (Azficel-T) | Fibrocell Technologies |
| 26 | LENMELDY (atidarsagene autotemcel) | Orchard Therapeutics (Europe) Limited |
| 27 | LUXTURNA (voretigene neparvovec-rzyl) | Spark Therapeutics, Inc. |
| 28 | LYFGENIA (lovotibeglogene autotemcel [lovo-cel]) | bluebird bio, Inc. |
| 29 | MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane) | Vericel Corp. |
| 30 | OMISIRGE (omidubicel-onlv) | Gamida Cell Ltd. |
| 31 | PROVENGE (sipuleucel-T) | Dendreon Corp. |
| 32 | REGENECYTE (HPC, Cord Blood) | StemCyte, Inc. |
| 33 | RETHYMIC (allogeneic processed thymus tissue – agdc) | Enzyvant Therapeutics GmbH |
| 34 | ROCTAVIAN (valoctocogene roxaparvovec-rvox) | BioMarin Pharmaceutical Inc |
| 35 | RYONCIL (remestemcel-L-rknd) | Mesoblast, Inc. |
| 36 | SYMVESS (acellular tissue engineered vessel-tyod) | Humacyte Global, Inc. |
| 37 | SKYSONA (elivaldogene autotemcel) | bluebird bio, Inc. |
| 38 | STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) | Stratatech Corporation |
| 39 | TECARTUS (brexucabtagene autoleucel) | Kite Pharma, Inc. |
| 40 | TECELRA (afamitresgene autoleucel) | Adaptimmune LLC |
| 41 | VYJUVEK (beremagene geperpavec) | Krystal Biotech, Inc. |
| 42 | YESCARTA (axicabtagene ciloleucel) | Kite Pharma, Incorporated |
| 43 | ZEVASKYN (prademagene zamikeracel) | Abeona Therapeutics, Inc. |
| 44 | ZYNTEGLO (betibeglogene autotemcel) | bluebird bio, Inc. |
| 45 | ZOLGENSMA (onasemnogene abeparvovec-xioi) | Novartis Gene Therapies, Inc. |
Content current as of:05/15/2025
Regulated Product(s):Biologics
Source: FDA