In a surprising about-face, the Meals and Drug Management will grasp a gathering of outdoor professionals to imagine whether or not or to not approve Sareptaâs experimental gene treatment for Duchenne muscular dystrophy.
The announcement Thursday comes simply weeks after the corporate mentioned the FDA had informed it an advisory panel assembly to study the remedy, referred to as SRP-9001, would now not be important. The verdict to study Sareptaâs gene treatment with out enter from outdoor professionals shocked some analysts and affected person advocates.
Release this newsletter by way of subscribing to STAT+ and experience your first 30 days loose!