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- FDA issues final guidance on potency standards for cell and gene therapy developersThe U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
- FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliffThe U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…