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

Smith also points out that the focus on Dato-DXd has overshadowed AstraZeneca’s promising non-oncology pipeline, which is expected to deliver significant developments between 2025 and 2028.

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

Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and ...

Neurogene has reported encouraging efficacy results with its gene therapy for rare genetic disorder Rett syndrome, but ...

The U.K. drugmaker also announced plans to drop another $2 billion on expanding its R&D and manufacturing footprint in the ...

In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — ...

For more information visit ClinicalTrials.gov. Datopotamab deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary ...

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

Daiichi Sankyo Company (DSKYF – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst ...