First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
The company has received five final approvals
US FDA approval based on NEURO-TTRansform Phase III results
The product is expected to be launched in FY25
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
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