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 ...

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

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial.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

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

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 ...

Additionally, a previously submitted BLA for a broader nonsquamous NSCLC indication had been voluntarily withdrawn.

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial.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 original application was based on results from a phase 3 trial of Dato-DXd. Data released in September 2024 on this trial ...

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

Three phase 3 trials of combinations including datopotamab deruxtecan for the treatment of non–small cell lung cancer are beginning.

TROPION-Lung01, evaluating Daiichi Sankyo and AstraZeneca (NASDAQ:AZN)'s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free... ByInvesting.com • ...