FDA Approves CLL Treatment under Project Orbis

FDA Approves CLL Treatment under Project Orbis

The FDA granted supplemental approval to Calquence (acalabrutinib), atreatment for adults with chronic lymphocytic leukemia (CLL) or small lyphocytic lymphoma (SLL). This approval was part of Project Orbis, a collaboration among the FDA, the Australian Therapeutic Goods Administration, and Health Canada, marking the second approval under the program. As a global provider of clinical packaging and courier services, Yourway has a breadth of knowledge of international regulations and supports more initiatives to harmonize regulations across nations.

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