AstraZeneca AZN and its Japanese partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation ...

AstraZeneca and Daiichi Sankyo have shared the data they believe can secure approval for datopotamab deruxtecan (Dato-DXd) at ...

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug ...

A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed that Daiichi Sankyo (DSKYF.PK) and ...

The data showed that patients with TROP2 positivity, as determined by QCS, experienced improved efficacy with Dato-DXd ...

A new BLA for Dato-DXd targets EGFR-mutated NSCLC, following withdrawal of a previous application based on TROPION-Lung01 trial data. The new submission is supported by phase 2 TROPION-Lung05 trial ...

A biomarker could help identify patients with lung cancer who are most likely to benefit from treatment with AstraZeneca and Daiichi Sankyo's TROP2-directed drug datopotamab deruxtecan (Dato-DXd).

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t ...

The firm cites the stock’s 24% decline over the past three months amid China government investigations and “disappointing” data on Dato-DXd lung potential for the upgrade. While significant China ...

The FDA is expected to decide on treatments for EBV-positive posttransplant lymphoproliferative disease, breast cancer, Barth syndrome, pain, and migraine.

US FDA grants breakthrough therapy designation to datopotamab deruxtecan for patients with previously treated advanced EGFR-mutated NSCLC: Cambridge, UK Tuesday, December 10, 2024 ...

At the conference, AstraZeneca and Daiichi Sankyo will present their case for Dato-DXd in NSCLC, while BioNTech and Merus ...