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FDA Grants Priority Review to Gedatolisib for HR+, HER2-Negative Advanced Breast Cancer

FDA Grants Priority Review to Gedatolisib for HR+, HER2-Negative Advanced Breast Cancer2+ hour, 14+ min ago   (570+ words) FDA grants Priority Review for gedatolisib, a promising treatment for advanced HR+/HER2- breast cancer, showcasing significant efficacy in recent trials. The FDA has formally accepted the New Drug Application (NDA) for gedatolisib (PF-05212384, PKI-587; Celcuity) in the treatment of hormone…...