U.S. FDA grants Priority Review for Roche's Enspryng for MOGAD, an autoimmune disease ...

The U.S. FDA has granted Priority Review to Roche's Enspryng for treating MOGAD, a rare autoimmune disease of the central nervous system with no approved treatments, based on strong Phase III trial results. A European Medicines Agency application is also validated, with decisions expected in early 2027 in the U.S. and Q3 2027 in Europe.

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