Biotech News
Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)
Cemdisiran could be the first siRNA approved for the treatment of gMG and only therapy to be offered subcutaneously with four times a year dosing FDA accepted NDA under Priority Review with a target action date in November 2026; European Commission decision anticipated in the second half of 2027