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Tezepelumab regulatory submission accepted and granted FDA priority review for the treatment of patients with asthma. AstraZeneca + Amgen

Read time: 1 mins
Last updated:28th Jul 2021
Published:8th Jul 2021
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the FDA. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.
Condition: Asthma ( Severe)
Type: drug
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