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- FDA releases details on accelerated approval process for personalized gene therapiesThe U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…
- Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trialsArtiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…