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FDA Grants Full Approval Following Inspection of the Phase 3 Clinical Trial Led by Prof. Gül Başaran

FDA Grants Full Approval Following Inspection of the Phase 3 Clinical Trial Led by Prof. Gül Başaran

Gloved hands pipetting in a class II biosafety cabinet
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The Phase III clinical study “TROPION-Breast 02” in the field of adult oncology, conducted under the leadership of Prof. Gül Başaran from the Department of Internal Medicine at our School of Medicine, was found to be fully compliant following an inspection by the U.S. Food and Drug Administration (FDA), with no observations reported.

Sponsored by AstraZeneca, the study received the highest number of patient contributions from Türkiye under the leadership of Prof. Başaran.

We sincerely congratulate Prof. Gül Başaran and the clinical research team on this outstanding achievement.

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