FDA Approvals | Cell therapy

Products regulated by the Food and Drug Administration comprise 25% of American consumer spending. The approaches used to approve these products can be as varied and complex as the products themselves. Such differences are dictated by Federal law and FDA identifies and enforces the relative risks and benefits that the products pose to consumers. These results convey summaries of products approved by FDA, including information about their past history and present status. The information not only applies to New Molecular Entities, but includes FDA approval information pertaining to new ingredients, dosages, therapeutic uses and generic equivalents.

Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

Active Ingredients

Active IngredientInnovator SponsorApproval YearsInnovator YearsInnovatorGenericType
autologous culture chondrocytesVericel Corporation1997 - 20161997 - 201620Cell therapy
allogeneic hematopoietic stem cellsNew York Blood Center2011 - 20242011 - 202490Cell therapy
azficel-TFibrocell Technologies, Inc.2011201110Cell therapy
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine CollagenOrganogenesis2012 - 20212012 - 202120Cell therapy
axicabtagene ciloleucelGilead Sciences2017201710Cell therapy
tisagenlecleucelNovartis2017201710Cell therapy
Brexucabtagene autoleucelGilead Sciences2020202010Cell therapy
lisocabtagene maraleucelBristol-Myers Squibb2021202110Cell therapy
ciltacabtagene autoleucelJohnson and Johnson2022202210Cell therapy
elivaldogene autotemcelbluebird bio2022202210Cell therapy
human fecal microbiotaFerring2022202210Cell therapy
donislecel-jujnCelltrans2023202310Cell therapy
Exagamglogene autotemcelAbbVie2023202310Cell therapy
fecal microbiota spores, live-brpkSeres Therapeutics2023202310Cell therapy
omidubicelGamida Cell2023202310Cell therapy
acellular tissue engineered vesselHumacyte, Inc.2024202410Cell therapy
Afamitresgene autoleucelAdaptimmune2024202410Cell therapy
Atidarsagene autotemcelKyowa Kirin2024202410Cell therapy
bone marrow derived mesenchymal stem cellsMesoblast, Inc.2024202410Cell therapy
lifileucelIovance2024202410Cell therapy
23 ingredients
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Approval Applications

Appl NoTypeApprovalSponsorActive IngredientsMarketing StatusClassPriority?Links

Submission class glossary

TYPE 1
New Molecular Entity
TYPE 2
New Active Ingredient
TYPE 3
New Dosage Form
TYPE 4
New Combination
TYPE 5
New Formulation or New Manufacturer
TYPE 6
New Indication (pre-2009)
TYPE 7
Drug Already Marketed without Approved NDA
TYPE 8
Partial Rx to OTC Switch
TYPE 9
New Indication or Claim (existing NDA)
TYPE 10
New Indication or Claim (additional NDA)
MEDGAS
Medical Gas