FDA lifts clinical hold on Mustang Bio's lentiviral gene therapy, paving the way for quick jump into pivotal trial
Things were looking good for Mustang Bio’s MB-107 gene therapy program. By early September, it had nabbed both rare pediatric disease and orphan drug designations, adding to the regenerative medicine advanced therapy designation it already scored at the FDA. It all boded well for the pivotal trial they were looking to start in newly diagnosed infants with X-linked severe combined immunodeficiency.
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