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Approvals in 2019: international review and a new agnostic molecular entity

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In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included… Click to show full abstract

In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

Keywords: review new; 2019 international; new agnostic; approvals 2019; oncology; international review

Journal Title: Nature Reviews Clinical Oncology
Year Published: 2020

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