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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.
WEBMedia Release Copenhagen, Denmark, February 24, 2020 U.S. FDA has accepted, with priority review, the sBLA submitted by Novartis for subcutaneous...
Administration (FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for ...
has accepted for Priority Review the supplemental Biologics License Application or sBLA for
WEBNov 30, 2023 · The sBLA for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found that the combination improved overall ...
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WEBMay 13, 2024 · The sBLA in adolescents is supported by an extrapolation of efficacy data from two positive pivotal trials (SINUS-24 and SINUS-52) in adults with CRSwNP. These trials demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic ...
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