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Fudin, R., Jaichenko, J., Shostak, A., Bennett, M

A., Gonzalez-Cantu, J

Gedatolisib for Advanced Breast Cancer: PDUFA 17 July 2026 Arguably the most clinically significant oncology FDA drug approval decision expected in July 2026 is the verdict on gedatolisib (Celcuity), with a PDUFA target action date of 17 July 2026