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Omidubicel - Gamida Cell

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Drug Profile

Omidubicel - Gamida Cell

Alternative Names: Cord blood stem cell therapy - Gamida Cell; CordIn; NiCord; omidubicel-onlv; Omisirge; UC MSC; Umbilical cord blood stem cell therapy - Gamida Cell; Umbilical cord mesenchymal stem cells

Latest Information Update: 06 Feb 2024

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At a glance

  • Originator Gamida-Cell
  • Class Antineoplastics; Mesenchymal stem cell therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hodgkin's disease; Haematological malignancies; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Myelodysplastic syndromes
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haematological malignancies
  • Phase I/II Aplastic anaemia; Haemoglobinopathies; Myelodysplastic syndromes; Sickle cell anaemia; Thalassaemia

Most Recent Events

  • 17 Jan 2024 Efficacy data from a phase III Expanded Access Program in Hematological malignancies released by Gamida Cell
  • 29 Sep 2023 Planned Prescription Drug User Fee Act (PDUFA) date for Haematological malignancies (In adolescents, In children, In adults) in USA (IV) is 2023-01-30
  • 27 Sep 2023 Launched for Haematological malignancies (In adolescents, In children, In adults) in USA (IV)

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