AstraZeneca and Daiichi Sankyo shared the pooled analysis behind the refiling of their TROP2 antibody-drug conjugate (ADC) ...

The FDA bestows a Breakthrough Therapy designation to AstraZeneca and Daiichi Sankyo's Dato-DXd for previously treated ...

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

The FDA has granted Breakthrough Therapy Designation to datopotamab deruxtecan (Dato-DXd) for advanced EGFR-mutated non-small cell lung cancer.

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

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

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

The two partners disclosed study results supporting an approval application for their drug dato-dxd. Elsewhere, Agenus cut ...

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

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

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

Kelun-Biotech has become the second drugmaker to bring a TROP2-directed antibody-drug conjugate to regulatory approval, ...