Posted by Michael Wonder on 24 Jun 2026
Cemdisiran regulatory submissions accepted for review by FDA and EMA for the treatment of generalised myasthenia gravis
22 June 2026 - Regeneron Pharmaceuticals today announced that both the US FDA and EMA have accepted the regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.
The FDA will review the new drug application under priority review with a target action date in November 2026, following use of a priority review voucher. A decision from the European Commission is anticipated in the second half of 2027.
