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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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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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WEBThe sBLA, along with other worldwide submissions, are supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or ...
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License Application (sBLA) for Priority Review for dupilumab (Dupixent), with the drug’s indication
WEBAug 24, 2021 · With the FDA granting a priority review to the sBLA, a decision from the
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rilonacept in recurrent pericarditis with priority review, said Sanj K. Patel, Chief Executive Officer and Chairman ...
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rilonacept in recurrent pericarditis with priority review, said Sanj K. Patel, Chief Executive Officer
and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental
granted priority review by the FDA. 1. In the pivotal phase 2/3 IND.227/KEYNOTE-483 trial, ...