Tag: Breast Cancer
Aurobindo Pharma achieves promising results for breast cancer biosimilar in Phase 3 trial
Aurobindo Pharma has announced positive results from a Phase 3 clinical trial of its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed ... Read More
Zydus Lifesciences secures tentative FDA approval for Palbociclib Tablets
Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has announced that it has been granted tentative approval by the US Food and Drug Administration ... Read More
Bayer gets Ultravist FDA approval for contrast-enhanced mammography
Bayer has received US Food and Drug Administration (FDA) approval for Ultravist (iopromide) injection, its iodine-based contrast agent, to be used for contrast-enhanced mammography (CEM). ... Read More
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) for pre-treated HR+/HER2- metastatic breast cancer. The ... Read More
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 the company’s Guardant360 CDx liquid biopsy assay ... Read More
Enhertu EU approval : Daiichi Sankyo, AstraZeneca get approval for HER2 low metastatic breast cancer
Daiichi Sankyo and AstraZeneca have received the approval of the European Union (EU) for their jointly developed Enhertu (trastuzumab deruxtecan) for the treatment of a ... Read More
Sun Pharma launches generic of breast cancer drug Palbociclib in India
Sun Pharmaceutical Industries (Sun Pharma) said that one of its fully-owned subsidiaries has launched the generic version of Pfizer-developed Palbociclib in India for patients with ... Read More
Zydus Lifesciences to commercialize OncoStem’s CanAssist Breast test
Zydus Lifesciences has secured exclusive marketing rights to CanAssist Breast, a prognostic test for breast cancer patients in the early stages, from Bengaluru-based OncoStem. According ... Read More
Alembic Pharmaceuticals gets FDA final approval for Paclitaxel Injection USP
Alembic Pharmaceuticals Limited has secured final approval for its abbreviated new drug application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 ... Read More
Gilead gets Trodelvy FDA priority review for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences said that Trodelvy (sacituzumab govitecan-hziy) has been granted priority review from the US Food and Drug Administration (FDA) for the treatment of another ... Read More