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

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

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: ...

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

In a significant move to alleviate the financial burden on patients, Finance Minister Nirmala Sitharaman announced in the ...

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

CORE EARNINGS PER SHARE: Core earnings per share are expected to rise to $2.07 from $1.45 the year prior, according to the same consensus. AstraZeneca's stock is up 7.9% since the start of 2024.

In February 2024, the government slashed GST (Goods and Services Tax) from three major cancer drugs: Trastuzumab Deruxtecan, ...