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Cellular Gene Therapy Products | FDA CBER has approved both cellular and gene therapy products – a list of these products may be found on the Approved Cellular and Gene Therapy Products webpage
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
100 cell and gene therapy leaders to watch in 2025 Through this multifactorial approach, the list highlights those making significant contributions to advancing the science and commercialization of cell, gene, and RNA therapies If you have suggestions or updated data to influence the rankings, feel free to reach out
Top 10 Best-Selling Cell and Gene Therapies - genengnews. com Topping our list of best-selling cell and gene therapies is Yescarta, a CAR T-cell therapy from Kite Pharma that brought in nearly $1 5 billion in 2023 To meet growing demand for Yescarta,
Cell and Gene Therapy Products: Navigating the Regulatory . . . - Springer Between 2020 and 2024, the FDA approved 25 Cell and Gene Therapy products, with 36% approved in 2024 The majority (34%) received Orphan Drug designation, followed by Breakthrough Therapy (20%) and RMAT (16%) Oncology led with 31% of approvals
2024 Breakthrough: 9 New Cell and Gene Therapies Approvals In 2024, new Cell and gene therapies (CGT) continued to make there way to the market, with the FDA approving nine innovative products in 2024 (FIG 1) These therapies include stem cell therapies, gene therapies, and CAR-T therapies Five of the 9 approvals occurred in the last 2 months of the year
Adaptimmune Receives U. S. FDA Accelerated Approval of TECELRA . . . TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U S , and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults
List of U. S. FDA Approved Cell and Gene Therapy Products (46) Below is a list of all known cell and gene therapy products that have been licensed by the Office of Tissues and Advanced Therapies (OTAT), a division of the U S FDA At present, 46 cell and gene therapies have been approved within the U S