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Herceptin News
Adjuvant Trastuzumab Emtansine Improves Overall Survival in HER2+ Breast Cancer
THURSDAY, Jan. 16, 2025 – For patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, adjuvant trastuzumab emtansine (T-DM1) improves overall survival more than...
FDA Approves Hercessi (trastuzumab-strf), a Biosimilar to Herceptin
DURHAM, N.C., April 29, 2024 /PRNewswire/ – Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care...
FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
South San Francisco, CA – June 29, 2020 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo,...
FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin
THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ – Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti...
FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
South San Francisco, CA – February 28, 2019 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin...
FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin
March 11, 2019 - Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the ...
FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Her...
FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
December 1, 2017 – The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic...
FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct 20, 2010 - Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab)...
FDA Medwatch Alert: Herceptin 440 mg Vials and BWFI Diluent
[Posted 07/10/2008] Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic...
FDA Medwatch Alert: Herceptin (trastuzumab)
[Posted 08/31/2005] Genentech and FDA notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical...
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Breast Cancer - Adjuvant, Breast Cancer, Breast Cancer, Metastatic, Gastric Cancer