The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

Novartis’ Kisqali (ribociclib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a ...

Alphamab Oncology (Stock Code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ('CSPC') (Stock Code: 1093.HK) jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has ...

A phase 2 trial finds that for patients with HER2+ metastatic colorectal cancer, dual HER2-inhibitor therapy can be a similarly efficacious but less toxic alternative to EGFR inhibitor therapy.

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: ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

The regulator approved the indication based on data showing Kisqali with an aromatase inhibitor improved invasive disease-free survival versus just an aromatase inhibitor.

Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated ...

A phase 3 clinical trial has shown that adding a targeted immunotherapy drug to chemotherapy dramatically improved – almost ...