Hi Steni ,
Things are changing on FDA Car T therapy as of January 2025.
https://www.asgct.org/publications/news/february-2024/final-fda-guidances-on-gene-editing-car-t-products
Also I interrogated Ai.
The statement that “the new FDA isn’t favouring anything cell-therapy, who knows what will happen to the CAR-T industry” is not accurate based on the latest evidence.
FDA’s Current Stance on Cell and CAR-T Therapies:
Ongoing Approvals and Guidance: The FDA continues to approve an increasing number of cell and gene therapies (CGTs), including CAR-T products. The agency’s guidance agenda for 2025 includes at least 14 new guidances focused on CGTs, demonstrating a strong ongoing commitment to advancing these therapies.
Recent Guidance for CAR-T: In January 2025, the FDA finalized guidance for the development of CAR-T cell products, incorporating feedback from industry and advocacy groups to allow for more regulatory flexibility, especially for innovative or one-time use materials. The guidance clarifies requirements, removes some overly burdensome recommendations, and maintains a focus on safety and efficacy.
Market Outlook: The CAR-T cell therapy market is experiencing rapid growth, with projections for the global market to increase from $12.88 billion in 2025 to over $128 billion by 2034. This growth is driv
Regulatory Focus: The FDA is highly focused on safety for these products, especially as the field expands into more complex indications. However, this does not equate to a blanket lack of support or an anti-cell therapy stance; rather, it reflects the agency’s responsibility to ensure patient safety as novel therapies are introduced.
Recent Developments:
While the FDA has issued Complete Response Letters (CRLs) and placed clinical holds on some cell therapy products in early 2025, this is consistent with its rigorous safety standards and not a sign of categorical opposition. Such regulatory actions are typical in areas of rapid innovation and do not indicate a hostile environment for cell therapies as a whole.en by continued FDA approvals, ongoing clinical trials, and strong investment in the sector.
Conclusion:
The FDA remains supportive of cell and gene therapies, including CAR-T, with ongoing approvals, updated guidance, and a robust pipeline of clinical trials. The agency’s approach is cautious and focused on safety, but there is no evidence of a broad shift against cell therapies or CAR-T products. The industry continues to grow rapidly, and the FDA’s actions reflect regulatory diligence rather than disfavor.
Plus I have invested fairly heavily and I seriously do my utmost to not make any mistakes. CHM is NASA science technology. People don't realise it yet.
Plus people don't understand the value attributable to the proprietary product Cdh17.
Part 5 the science explained on Wednesday, hope you guys and gals are looking to improve your knowledge!
Its improving mine.
I receive all FDA updates . Today was a grand one. They are using Ai to streamline waiting times on decision making. To some people it's a tool , to me it's a multi level lateral think tank.
I put all my work through it to fast check accuracy.
Kpax
(20min delay)