AstraZeneca Pharma India gets CDSCO approval for Enhertu for new breast cancer indication Ruchika Sharma9 May 2025 3:31 PM ISTBangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu Ruchika Sharma1 Feb 2025 12:30 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5)...
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA approval for HER2-ultralow metastatic breast cancer Ruchika Sharma28 Jan 2025 2:30 PM ISTAstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with...
Addition of AstraZeneca breast cancer drug Enhertu to China state insurance list Ruchika Sharma29 Nov 2024 5:29 PM ISTChina: Enhertu, a blockbuster breast cancer drug of AstraZeneca, will be included in China's state-run health insurance scheme from January 1, as per...
USFDA grants priority review to AstraZeneca-Daiichi Sankyo Enhertu for HER2-low, HER2 Ultralow Breast Cancer Ruchika Sharma3 Oct 2024 9:15 AM ISTAstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and...
Daiichi Sankyo, AstraZeneca Enhertu gets USFDA breakthrough therapy designation for certain patients with HER2 low or HER2 ultralow metastatic breast cancer Ruchika Sharma21 Aug 2024 3:37 PM ISTTokyo: ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable...
AstraZeneca-Daiichi Sankyo Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer Ruchika Sharma15 Aug 2024 10:30 AM ISTCambridge: AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for...
Roche gets CE Mark for companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for Enhertu Ruchika Sharma12 April 2024 12:54 PM ISTTucson: Roche has announced the approval of the CE Mark for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify...
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA accelerated nod for metastatic HER2-positive solid tumours Ruchika Sharma7 April 2024 11:30 AM ISTCambridge: AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients...
AstraZeneca India bags dual CDSCO nod for Trastuzumab deruxtecan Ruchika Sharma28 March 2024 1:30 PM ISTBangalore: AstraZeneca Pharma India Limited has received permission to import for sale and distribution of Trastuzumab deruxtecan lyophilized...
AstraZeneca Enhertu granted priority review in US for metastatic HER2-positive solid tumours Ruchika Sharma31 Jan 2024 12:45 PM ISTCambridge: AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been...
Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg Dr. Divya Colin29 Dec 2023 6:15 PM ISTNew Delhi: In response to the drug major AstraZeneca's proposal for the additional indication of Trastuzumab Deruxtecan Powder Concentrate Solution...
