Browsing Tag
Metastatic breast cancer
18 posts
Celcuity moves gedatolisib toward U.S. approval with NDA filing for HR+/HER2- advanced breast cancer patients
Discover how Celcuity’s FDA review for gedatolisib could expand treatment choices for HR+/HER2- PIK3CA wild-type advanced breast cancer patients.
November 17, 2025
Tempus AI and Stemline Therapeutics partner to advance AI-driven ESR1 mutation testing in metastatic breast cancer
Tempus AI, Inc. (NASDAQ: TEM) and Stemline Therapeutics, Inc., a wholly owned subsidiary of the Menarini Group, have…
February 23, 2025
Roche secures FDA approval for HER2-ultralow metastatic breast cancer diagnostic
Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, marking a significant…
February 2, 2025
Datroway approved in US: A new era in metastatic breast cancer treatment
In a landmark decision, the US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan), a first-in-class…
January 19, 2025
Breakthrough in breast cancer treatment? BriaCell Therapeutics shares soar 150%!
BriaCell Therapeutics Corp., a clinical-stage biotechnology company, saw its shares surge by more than 150% to $1.55 following…
September 11, 2024
Gilead’s Trodelvy gains EC approval as new hope for metastatic breast cancer patients
In a significant advancement for cancer treatment, the European Commission (EC) has approved Gilead Sciences’ Trodelvy (sacituzumab govitecan)…
July 27, 2023
Menarini’s ORSERDU gets CHMP positive opinion in advanced breast cancer
The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines…
July 22, 2023
AstraZeneca, Daiichi Sankyo’s Enhertu approved for breast cancer in China
The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab…
July 15, 2023
Gilead gets Trodelvy FDA approval for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Trodelvy (sacituzumab govitecan-hziy)…
February 10, 2023
FDA approves Guardant360 CDx assay as companion diagnostic for Menarini’s ORSERDU for metastatic breast cancer
Guardant Health, an oncology company, has secured the approval of the US Food and Drug Administration (FDA) for…
February 1, 2023