Drug Approval | November 22, 2023
Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
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
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
Farxiga is expected to have such a strong influence on the market due to the impressive results
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Franson will help biopharma clients design a phased approach to inform and execute clinical development plans
China is among the top countries reporting a high number of diagnosed prevalent cases for gastric, breast, and bladder cancers among the 16 major markets
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