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WEBSanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for the blockbuster medicine Dupixent for ...
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WEBMay 13, 2024 · Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of
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WEBMay 13, 2024 · (RTTNews) - The U.S. Food and Drug Administration has accepted for Priority
WEBThe sBLA, as well as other submissions around the world, is supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation (screening blood eosinophils >300...
WEBThe sBLA application is supported by positive data from the randomised, global, multicentre, open-label Phase III IMROZ clinical trial of Sarclisa plus standard-of-care VRd. The study enrolled 446 patients across 21 countries and 104 centres.
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WEBMedia Release Copenhagen, Denmark, February 24, 2020 U.S. FDA has accepted, with priority review, the sBLA submitted by Novartis for subcutaneous...
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