FDA grants Breakthrough Therapy Designation status for acalabrutinib
It has been announced that the FDA has awarded AstraZeneca’s acalabrutinib product for MCL treatment Breakthrough Therapy Designation...
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It has been announced that the FDA has awarded AstraZeneca’s acalabrutinib product for MCL treatment Breakthrough Therapy Designation...
AstraZeneca and Acerta Pharma have announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product.