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Taiwan News
1 小时
Anti-HER2 Bispecific ADC JSKN003 Received Approval to Initiate a Phase III Clinical Study ...
("CSPC") (Stock Code: 1093.HK) jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the Center for Drug Evaluation (CDE) of the National ...
BioPharma Dive
7 天
Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
5 天
FDA approves Datroway for HR-positive, HER2-negative breast cancer
The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...
2 天
FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
Targeted Oncology
2 天
T-DXd Reevaluated in HER2-Low/HER2-Negative Breast Cancer After New Trials
During a Case-Based Roundtable event, Laura Huppert, MD, discussed data and considerations around using T-DXd in breast ...
Cure Today
9 天
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
pharmaphorum
8 天
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
Targeted Oncology
13 小时
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
PMLiVE
19 小时
Novartis’ Kisqali granted MHRA approval to treat early breast cancer patients
Novartis’ Kisqali (ribociclib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a ...
The American Journal of Managed Care
8 天
FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
Cure Today
6 天
Itovebi-Based Treatment Has OS Benefit in PIK3CA+ HR+/HER2– Breast Cancer
Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated ...
Pharm Exec
1 天
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
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