Also known as Enspryng.
FDA accepted the application for satralizumab for adult and adolescent MOGAD and granted Priority Review with a decision due 10 Jan 2027; EMA validated the MAA, EC decision expected Q3 2027.
FDA to decide by 10 Jan 2027 on satralizumab for MOGAD after Phase III METEOROID showed 68% relapse risk reduction; EMA validation pending EC decision in Q3 2027.
Priority Review follows Phase III METEOROID showing 68% relapse risk reduction; FDA decision expected Jan 10, 2027; EMA validated the MOGAD filing with EC decision due Q3 2027.
Regulatory submission seeks approval of satralizumab to prevent relapse in MOG antibody‑associated disease after Phase III showed a 68% risk reduction.
FDA accepted an sBLA and granted Priority Review for the first at‑home subcutaneous option for thyroid eye disease; decision expected 15 Oct 2026.
