FDA Reversal On uniQure Gene Therapy Is Another Sign Of Renewed Regulatory Flexibility (opens in new tab)

UniQure is preparing to seek accelerated FDA approval for its Huntington’s disease gene therapy, a move that follows the FDA’s reversal of its prior position calling for another clinical trial. This gene therapy is the latest in a growing list of rare disease treatments to receive reconsideration from an FDA that appears to be swinging back to regulatory flexibility.