Veterinary Packaging Shijiazhuang Xinfuda Medical Packaging Co., Ltd.

E-MAIL: [email protected]

FDA-DMF Query
Home > News

FDA Approved Cellular and Gene Therapy Products

Jan 15 , 2026

Below is a list of licensed products from the Office of Therapeutic Products (OTP).

Approved Products

Product & Trade NameManufacturer
ABECMA (idecabtagene vicleucel)Celgene Corporation, a Bristol-Myers Squibb Company
ADSTILADRIN (nadofaragene firadenovec-vcng)Ferring Pharmaceuticals A/S
ALLOCORD (HPC, Cord Blood)SSM Cardinal Glennon Children's Medical Center
AMTAGVI (lifileucel)Iovance Biotherapeutics, Inc.
AUCATZYL (obecabtagene autoleucel)Autolus Limited
BEQVEZ (fidanacogene elaparvovec-dzkt)Pfizer, Inc.
BREYANZI (lisocabtagene maraleucel)Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
CARVYKTI (ciltacabtagene autoleucel)Janssen Biotech, Inc.
CASGEVY (exagamglogene autotemcel [exa-cel])Vertex Pharmaceuticals Incorporated
CLEVECORD (HPC Cord Blood)Cleveland Cord Blood Center
Ducord, HPC Cord BloodDuke University School of Medicine
ELEVIDYS (delandistrogene moxeparvovec-rokl)Sarapeta Therapeutics, Inc.
ENCELTO (revakinagene taroretcel-lwey)Neurotech Pharmaceuticals, Inc.
GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)Organogenesis Incorporated
HEMACORD (HPC, cord blood)New York Blood Center
HEMGENIX (etranacogene dezaparvovec-drlb)CSL Behring LLC
HPC, Cord BloodClinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord Blood - MD Anderson Cord Blood BankMD Anderson Cord Blood Bank
HPC, Cord Blood - LifeSouthLifeSouth Community Blood Centers, Inc.
HPC, Cord Blood - BloodworksBloodworks
IMLYGIC (talimogene laherparepvec)BioVex, Inc., a subsidiary of Amgen Inc.
ITVISMA (onasemnogene abeparvovec-brve)Novartis Gene Therapies, Inc.
KEBILIDI (eladocagene exuparvovec-tneq)PTC Therapeutics
KYMRIAH (tisagenlecleucel)Novartis Pharmaceuticals Corporation
LANTIDRA (donislecel)CellTrans Inc.
LAVIV (Azficel-T)Fibrocell Technologies
LENMELDY (atidarsagene autotemcel)Orchard Therapeutics (Europe) Limited
LUXTURNA (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 GmbH
ROCTAVIAN (valoctocogene roxaparvovec-rvox)BioMarin Pharmaceutical Inc
RYONCIL (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 Corporation
TECARTUS (brexucabtagene autoleucel)Kite Pharma, Inc.
TECELRA (afamitresgene autoleucel)Adaptimmune LLC
VYJUVEK (beremagene geperpavec-svdt)Krystal Biotech, Inc.
WASKYRA (etuvetidigene autotemcel) Fondazione Telethon ETS
YESCARTA (axicabtagene ciloleucel)Kite Pharma, Incorporated
ZEVASKYN (prademagene zamikeracel)Abeona Therapeutics, Inc.
ZYNTEGLO (betibeglogene autotemcel)bluebird bio, Inc.
ZOLGENSMA (onasemnogene abeparvovec-xioi)Novartis Gene Therapies, Inc.

Source from FDA


Polymer Vial for cell and gene therapies

Polymer Vial 2ml 5ml 10ml for cell and gene therapies

RTU vial

RTU vial


Back to List
Share:
HOT PRODUCTS
twitter facebook youtube linkedin pinterest

Copyright © Shijiazhuang Xinfuda Medical Packaging Co., Ltd. All Rights

Reserved Powered by    

MAKE AN ENQUIRY

verification

wechat