AstraZeneca’s supplemental New Drug Application, or sNDA, for Calquence has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with previously untreated mantle cell lymphoma, or MCL, the company announced. “The Food and Drug Administration grants Priority Review to applications for medicines that, if approved, would offer significant improvements 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 anticipated during the first quarter of 2025,” the company stated.
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