FDA’s Outlook Dims for New Regenerative Therapies in Covid Era

Oct. 12, 2021, 8:16 PM

The regenerative medicine surge anticipated in the next few years will likely be on the lower end as the FDA reels from the Covid-19 pandemic.

Regulators and industry expected 10 to 25 new cell and gene therapy products to come online starting in 2025 as scientific advances have led to a booming industry of cutting-edge products that can repair or replace genetic material that causes disease. Novartis broke open the market in 2017 with Kymriah to treat a form of acute lymphoblastic leukemia, and there are now more than 1,000 investigational new drug applications for cell and gene therapy products. ...

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