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October 4, 2024

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

The FDA will provide a decision on Calquence for the treatment of previously untreated mantle cell lymphoma by the first quarter of 2025. Credit: Narupon Promvichai from Pixabay.