Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.

Fact checked by Nick Blackmer The Food and Drug Administration (FDA) recently approved a new targeted chemotherapy drug for ...

Enhertu achieved a median progression-free survival of 13.2 months versus 8.1 months for chemotherapy, with a higher objective response rate of 62.6% compared to 34.4%. This summary was ...

The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the USA as the first HER2-directed ...

In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...

New approval brings the medicine to an earlier treatment setting and a broader patient population.

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 ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...