MediWound Announces U.S. FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
MediWound Ltd. - Ordinary Shares (MDWD)
Last mediwound ltd. - ordinary shares earnings: 2/25 07:00 am
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Source: GlobeNewswire
YAVNE, Israel, Aug. 03, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (“MediWound”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently re-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 January 1, 2023. “We are thrilled to have our application accepted and to be one step closer to commercializing NexoBrid in the U.S. We have seen NexoBrid help burn patients worldwide and knowing that it may be soon available in the United States is very gratifying,” said Ofer Gonen, CEO of MediWound. “We thank both Vericel and BARDA for their leadership and commitment to this important program.” The BLA
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News
- MediWound Ltd. (NASDAQ: MDWD) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
- MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care Conferences [Yahoo! Finance]Yahoo! Finance
- MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care ConferencesGlobeNewswire
- MediWound Ltd. (NASDAQ: MDWD) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- What Makes MediWound (MDWD) a Good Fit for 'Trend Investing' [Yahoo! Finance]Yahoo! Finance
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