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Biotech giant Agenus opening on 120 acres in Vacaville
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Galderma Gains Exclusive Licenses for Acne and Rosacea Topicals
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FDA to Review Vutrisiran for Polyneuropathy of Hereditary ATTR Amyloidosis
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Date Time
Tezepelumab regulatory submission accepted and granted FDA Priority Review
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (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.
1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.
Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.
Amgen: FDA Grants Priority Review For Tezepelumab In Treatment Of Asthma
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