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Sanofi (SNY), Regeneron's Dupixent sBLA Gets FDA Priority Tag

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 ...

Investor.regeneron.com

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for ...

WEBMay 13, 2024 · Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of

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Markets.businessinsider.com

Regeneron : Dupixent SBLA Accepted For FDA Priority Review …

WEBMay 13, 2024 · (RTTNews) - The U.S. Food and Drug Administration has accepted for Priority

Dupixent® sBLA accepted for FDA Priority Review for treatment of …

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...

Pharmaceutical-technology.com

FDA accepts Sanofi’s Sarclisa sBLA for priority review

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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