Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
GlobalData on MSN4d
FDA expands Enhertu approval to include HER2-ultralow breast cancer patientsAstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
Zacks.com on MSN5d
FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationThe FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
UK’s most valuable listed company raised NHS rejection of its new breast cancer drug and the drug pricing mechanism during negotiations ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
Tokyo: Daiichi Sankyo Company, Ltd has appointed Hiroyuki Okuzawa, 62, to succeed Sunao Manabe, DVM, Ph.D. as Chief Executive ...
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
Q3 2024 Management View Revenue for Q3 FY2024 increased 16.6% year-on-year to ¥1,367.6 billion, driven by growth in oncology ...
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
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