Articles in this Issue

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  Changes: A turbulent year for FDA oversight

  Friday, January 02, 2026
  Characterizing 2025 from a regulatory perspective is uniquely challenging. Perhaps David Bowie said it best when he said, “I don’t know where I’m going from here, but I promise it won’t be boring.” read more
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  From centralized to decentralized

  Wednesday, February 04, 2026
  A decentralized model for cell-based products offers various benefits including fresh tissues and drug products, reduced costs, and shorter treatment times. read more
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  What sponsors should know about FDA’s platform technology designation

  Tuesday, January 20, 2026
  Sponsors with a licensed gene therapy can use the same vector platform to reference manufacturing, analytical and safety data for other candidates. read more
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  Narrowing the CGT access gap

  Tuesday, January 27, 2026
  There is significant opportunity to expand the applications of cell therapy further into rare diseases as well as to tackle widespread conditions. read more
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  Little fish, big waves

  Tuesday, January 13, 2026
  A powerful shift is underway within the rare disease space. It started as a handful of inspiring stories of parents stopping at nothing to save the lives of their children. But while this patient ... read more
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  Swimming upstream

  Wednesday, February 18, 2026
  Rare and ultra-rare disease patients have long been forced to struggle upstream. read more