The Menarini Group and its subsidiary, Stemline Therapeutics, Inc., have made a significant stride in breast cancer treatment with new findings from the pivotal EMERALD clinical study. These findings were recently presented at the 2023 San Antonio Breast Cancer Symposium (SABCS). The post hoc analysis of the EMERALD study demonstrated a clinically meaningful improvement in […]
The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the approval of ORSERDU (elacestrant) monotherapy. This treatment is intended for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer […]
Guardant Health, an oncology company, has secured the approval of the US Food and Drug Administration (FDA) for the company’s Guardant360 CDx liquid biopsy assay as a companion diagnostic for ORSERDU (elacestrant). The FDA approval as a companion diagnostic for ORSERDU marks Guardant Health’s first in breast cancer and the fifth for the Guardant360 CDx […]