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英文字典中文字典相关资料:


  • Updated 2025 List of FDA-Approved Cell and Gene Therapies
    Professor's list of FDA-approved cell and gene therapies including stem cell therapies that have received FDA approval
  • US Approved Gene Therapies and Summary Basis for Approvals
    For each approved gene therapy, FDA publishes the product approval and review information on their website by year The clinical evidence of effectiveness is provided to the public for transparency For those 19 approved gene therapies, "Summary Basis for Regulatory Action" documents were reviewed and some basic information was summarized in the table below
  • FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
    FDA approves Roctavian, the first adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A
  • A Slow Embrace: Hemophilias Gradual Adoption of Gene Therapy
    The treatment landscape for patients with hemophilia has been enriched with one-time gene therapies, as of the November 2022 United States (US) approval of etranacogene dezaparvovec and the June 2023 US approval of valoctocogene roxaparvovec, both adeno associated virus (AAV) vector gene therapies 1,2 UniQure and CSL Behring’s etranacogene dezaparvovec, marketed as Hemgenix, is approved for
  • Gene therapy for hemophilia - American Society of Hematology
    Long-term clinical studies have provided insight into the efficacy, safety, and durability of AAV-mediated gene therapies for hemophilia A 12 and B 3-5 Gene therapies have now been approved for hemophilia A (valoctocogene roxaparvovec) and hemophilia B (etranacogene dezaparvovec and fidanacogene elaparvovec) in select regions
  • Cell and Gene Therapy Products: Navigating the Regulatory . . . - Springer
    Purpose The purpose of this research is to analyze regulatory approvals of Cell and Gene Therapy Products by the FDA from 2020 to 2024 The study aims to explore the utilization of expedited regulatory pathways, including RMAT designation, and their impact on the approval trends of cell and gene therapies Additionally, the research investigates therapeutic area-specific trends and highlights
  • Approved cell and gene therapy (CGT) products
    NEWDIGS maintains a list of approved durable cell and gene therapies (CGT), including approval dates for new biologics as well as supplemental indications Durable cell and gene products are designed for one-time use, as compared to products which are administered more than once All therapies on this list have gone through the FDA’s drug approval process, which is designed to ensure that
  • 2023: A Record Year for Cell Gene Therapy Approvals
    2023 was a breakthrough year for cell and gene therapies The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline 2024 looks to be another important year with up to 17 new therapies poised for regulatory approval
  • The Gene Cell Therapy Landscape: Recent Approvals and Upcoming . . .
    Here we take a glance at the recent advancements in therapy approvals and clinical developments across various disease areas, highlighting recent advancements in gene, cell, and RNA therapies, along with breakthroughs in hematology, neurodegenerative disorders, genetic diseases, and blood disorders Current Advancements in Therapy Approvals and Clinical Development Globally, there are
  • Approval and therapeutic value of gene therapies in the US and . . . - Nature
    To better understand the clinical importance of the current landscape of approved gene therapies, we conducted a systematic analysis of the approved gene therapies and their added therapeutic value





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