AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US ...

AstraZeneca, Daiichi Sankyo seek US FDA’s accelerated approval for datopotamab deruxtecan to treat advanced EGFR-mutated NSCLC ...

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

One investigation discussed during the call involves sales reps in China allegedly changing genetic testing results to secure reimbursement for Tagrisso.

A team of researchers have applied a novel blood test that can detect early signs of potentially fatal lung damage in cancer ...

Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer AstraZeneca and Daiichi Sankyo's new ...

LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of ...

On the regulatory front, AstraZeneca, in collaboration with Daiichi Sankyo, said it had submitted a new biologics licence ...

The 2024 China Aviation Industry Conference and Nanchang Air Show was held at Yaohu Airport in Nanchang National High-tech Industrial Development Zone of east China's Jiangxi Province from November 2 ...

Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer Daiichi Sankyo (TSE: 4568) and ...

AstraZeneca (AZN) and Daiichi Sankyo have submitted a new Biologics License Application for accelerated approval in the US for datopotamab deruxtecan for the treatment of adult patients with locally ...

ADCs, including the widely used cancer drug Enhertu (trastuzumab deruxtecan), represent a new wave of targeted therapies.