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UCB : receives European Commission approval for BIMZELX▼(bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa

UCB receives European Commission approval for BIMZELX[®]▼ as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa

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Bruxelles Capitale , Eimear Obrien , Antje Witte , Klinikum Dessau , Laurent Schots , Barry Mcgrath , Emmanuel Caeymaex , J Clin Pharmacol , Corporate Communications , Immunology Solutions , Brandenburg Medical School , Brand Communications , European Union , European Commission , European Hidradenitis Suppurativa Foundation , Medicinal Products , Human Use , European Medicines , Executive Vice President , Important Safety , Euronext Brussels , Rev Dis ,

FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and Additional

Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where bimekizumab-bkzx showed clinically meaningful improvements vs. placebo at Week 16 which were sustained to Week 48Application for the additional bimekizumab-bkzx 2mL device presentations aims to provide more opt. ....

Emmanuel Caeymaex , Drug Administration , European Union , European Union Economic Area , Immunology Solutions , Biologics License Application , Executive Vice President , Important Safety Information , Herpes Simplex Infections , Important Safety , Product Characteristics , European Economic ,

UCB : FDA Accepts Supplemental Biologics License Applications for BIMZELX (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations -April 04, 2024 at 01:04 am EDT

FDA Accepts Supplemental Biologics License Applications for BIMZELX[®] for Moderate to Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations

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Bruxelles Capitale , Antje Witte , J Clin Pharmacol , Laurent Schots , Eimear Obrien , Emmanuel Caeymaex , European Union , Drug Administration , Immunology Solutions , Brand Communications , Corporate Communications , Biologics License Application , Executive Vice President , Important Safety Information , Herpes Simplex Infections , Important Safety , Euronext Brussels , Oral Presentation , Rev Dis ,

FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations

/PRNewswire/ UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the. ....

Bruxelles Capitale , Erica Puntel , Antje Witte , Hidradenitis Suppurativa , Emmanuel Caeymaex , Group Of Companies , Drug Administration , Ucb Inc , Immunology Solutions , Us Communications , Biologics License Application , Executive Vice President , Important Safety Information , United States , Herpes Simplex Infections , Euronext Brussels , Oral Presentation , Rev Dis , Clin Cosmet Investig , Its Effect , Study Participants With Moderate , Severe Hidradenitis Suppurativa ,

Bimekizumab Under Review for Moderate to Severe Hidradenitis Suppurativa

The FDA has accepted for review the sBLA for bimekizumab-bkzx for the treatment of adults with moderate to severe hidradenitis suppurativa. ....

Emmanuel Caeymaex , Immunology Solutions , Drug Administration , Biologics License Application , Hidradenitis Suppurativa Clinical Response , Executive Vice President ,