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The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial. The ...

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial. The ...

Additionally, a previously submitted BLA for a broader nonsquamous NSCLC indication had been voluntarily withdrawn.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries across the globe. It is approved as a single-use pre-filled syringe and auto-injector ...

in the TROPION-Lung01 study. There was also an “early trend” towards an improvement in overall survival with the ADC, although that data isn’t yet mature, said the drugmakers in a joint ...

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 original application was based on results from a phase 3 trial of Dato-DXd. Data released in September 2024 on this trial ...

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

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

The 22nd Annual Winter Lung Cancer Conference, January 31-February 2, 2025, will cover advances in NSCLC and SCLC treatment.