Mallinckrodt's MNK-1411 gets orphan drug status for DMD | DuchenneXchange

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Mallinckrodt’s MNK-1411 gets orphan drug status for DMD


Mallinckrodt plc MNK announced that the FDA has granted orphan drug designation to its pipeline candidate – MNK-1411, which is being evaluated for the treatment of Duchenne muscular dystrophy (DMD). The candidate has received a Fast Track designation by the FDA for the same indication. MNK-1411 is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions but has not been approved in the U.S.

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