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Tezepelumab Granted Priority Review By U.S. FDA

Tezepelumab Granted Priority Review By U.S. FDA
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World Allergy Week 2021 Launches Today to Raise Awareness of A... ( MILWAUK...)

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World Allergy Week 2021 Launches Today to Raise Awareness of Anaphylaxis

MILWAUKEE, June 13, 2021 /PRNewswire-PRWeb/ World Allergy Organization (WAO), serving its membership of professional allergy/immunology societies around . ....

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New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients

/PRNewswire/ Amgen (NASDAQ:AMGN) and AstraZeneca today announced detailed results for tezepelumab, a potential first-in-class treatment, from the pivotal. ....

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Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA

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THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.
1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials. ....

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