Precision Medicine Online

AstraZeneca Readying for Breast Cancer Franchise Growth Led by Enhertu, Datroway, Camizestrant

The firm is anticipating approvals in 2026 to push Enhertu into earlier breast cancer indications and Datroway into ...
Seeking Alpha

DATROWAY® Granted Priority Review in the U.S. as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy

“DATROWAY potentially could be the first medicine approved in the first-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared ...
Seeking Alpha

Astra wins FDA priority review for Daiichi’s Datroway; denied approval for lupus therapy

AstraZeneca (AZN) announced on Tuesday that the U.S. FDA has granted priority review for a marketing application seeking a label expansion for its cancer therapy Datroway, marketed with Daiichi Sankyo ...
Nasdaq

FDA Rejects AZN's Saphnelo SubQ Formulation, Priority Tag to Datroway

AstraZeneca AZN and its Japan-based partner Daiichi Sankyo announced that the FDA has accepted and granted priority review to their supplemental biologics license application (sBLA) seeking approval ...
FierceBiotech

Daiichi stops internal development of next-wave ADC as key Datroway readout delayed again

Daiichi Sankyo’s development of antibody-drug conjugates continues to hit turbulence. Despite the success of Enhertu, the company has experienced two latest hiccups: the discontinuation of internal ...