The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.

Trastuzumab emtansine (T-DM1) demonstrates sustained improvement in invasive disease-free survival and reduced the risk for death in human epidermal growth factor receptor 2 (HER2)-positive breast ...

Patients could receive trastuzumab to complete therapy if T-DM1 was discontinued early. 2 Statistical methods and assumptions for the primary analysis have been described in detail 2; the same ...

The development, pharmacology, safety, efficacy, and dosage and administration of trastuzumab are reviewed. The discovery of HER2 gene amplification in up to 30% of women with breast cancer led to ...

received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by ...

The department has also upgraded its computer systems and marriage registration forms to enable the registration of same-sex marriages promptly once the bill becomes law. “A trial run was carried out ...