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(RTTNews) - MediWound Ltd. (MDWD) announced the FDA has completed their filing review and accepted a supplement to the NexoBrid biologics license application for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. The company noted that, if approved, NexoBrid will serve as an effective non-surgical treatment for both pediatric and adult burn patients in the U.S.
NexoBrid received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns. The sBLA seeks to expand the label to include both adult and pediatric burn patients of all ages.
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