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- FDA issues final guidance on potency assurance for cell and gene therapy manufacturersThe FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
- FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosisThe U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…