The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
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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 ...
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: ...
Seiji Wakao, JPMorgan, queried the feasibility of achieving ¥1 trillion in oncology revenue amid Datroway’s setbacks. Ogawa stated that ENHERTU’s performance could potentially fill the gap, with a ...
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
AstraZeneca scrapped plans for a £450 million UK vaccine plant after rejecting a £78 million government offer, citing ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
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