MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
MediWound Ltd. - Ordinary Shares (MDWD)
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Source: GlobeNewswire
YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “MediWound”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. “The FDA’s acceptance of the NexoBrid BLA submission for review is a major milestone for MediWound, and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States,” said Sharon Malka, CEO of MediWound. “We tha
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