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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 approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concernsThe U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…