Following their recent groundbreaking approvals, products like Novartis AG’s Kymriah (tisagenlecleucel) and Gilead Sciences Inc.’s Yescarta (axicabtagene ciloleucel) may be hogging the limelight where advanced therapies are concerned, but behind the scenes there are still many gaps to bridge before the whole gamut of cell, tissue and gene therapy products can be adequately regulated.
While a great deal of progress has been made so far on dedicated pathways and guidelines, the regulation of advanced...
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