Menarini’s ORSERDU gets CHMP positive opinion in advanced breast cancer

Pallavi Madhiraju- July 22, 2023

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 ... Read More

AstraZeneca, Daiichi Sankyo’s Enhertu approved for breast cancer in China

Pallavi Madhiraju- July 15, 2023

The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in ... Read More

Aurobindo Pharma achieves promising results for breast cancer biosimilar in Phase 3 trial

Pallavi Madhiraju- July 4, 2023

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

Pallavi Madhiraju- June 28, 2023

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

Pallavi Madhiraju- June 23, 2023

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

Raghuram Kadari- February 10, 2023

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

Raghuram Kadari- February 1, 2023

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

Raghuram Kadari- January 29, 2023

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

Pallavi Madhiraju- January 11, 2023

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

Pallavi Madhiraju- November 16, 2022

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