FDA Updates Potency Rules for Cell and Gene Therapies
Replacing guidance from 2011, the FDA's updated framework emphasizes potency assurance throughout cell and gene therapy development and manufacturing
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Replacing guidance from 2011, the FDA's updated framework emphasizes potency assurance throughout cell and gene therapy development and manufacturing
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November 11, 2026
2 min read
Replacing guidance from 2011, the FDA's updated framework emphasizes potency assurance throughout cell and gene therapy development and manufacturing
November 11, 2026
2 min read
The deal adds viral vector, bioconjugation, payload-linker, and advanced drug-delivery capabilities to Lonza’s manufacturing network
November 3, 2026
2 min read
The company also reported early efficacy and safety data from the Phase I Breakfree-2 study
November 2, 2026
2 min read
Phase I data show B-cell depletion and mostly stable or improved disability scores, but the uncontrolled study remains small and follow-up is limited
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