AstraZeneca Plc's AZN supplemental New Drug Application for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the U.S. for locally advanced ...

AstraZeneca and Daiichi Sankyo have submitted a Biologics License Application (BLA) to the FDA for accelerated approval of datopotamab deruxtecan (Dato-DXd), targeting adults with previously treated, ...

By Najat Kantouar AstraZeneca said it and Daiichi Sankyo decided to voluntarily withdraw the marketing authorization application in the European Union for advanced lung-cancer treatment Dato-DXd ...

While the application for datopotamab deruxtecan in NSCLC has been withdrawn, another application by AstraZeneca and Daiichi Sankyo for the drug's use in hormone receptor (HR)-positive, HER2 ...

AstraZeneca PLC (LSE:LON: AZN), a pharmaceutical giant with a market capitalization of $203 billion and impressive gross profit margins of 83%, and its partner Daiichi Sankyo have decided to withdraw ...

The highly redacted FDA Form 483 was issued (PDF) to AstraZeneca’s ZS Pharma unit following a January inspection of its plant in Coppell, Texas.

Sacramento, Calif.-based Sutter Health has joined forces with biopharmaceutical company AstraZeneca to develop a research and innovation collaboration focused on personalized care for ...

AstraZeneca and Merck & Co. will work together to broaden the application of AstraZeneca’s Lynparza, a small-molecule PARP inhibitor approved in 2014 to treat BRCA-mutated ovarian cancer.

WuXi AppTec (WuXi) has announced that it has formed a strategic alliance with MedImmune, the global biologics research and development arm of AstraZeneca. This strategic alliance will bring ...

The IND application was subsequently accepted by CFDA for review in March 2015. WuXi will continue manufacturing for the program at its biologics facilities, the first in China to meet cGMP standards ...

AstraZeneca and Targacept will jointly design a global Phase 3 clinical program anticipated to begin in mid 2010 with the goal of filing a new drug application (NDA) with the US Food and Drug ...

AstraZeneca and Targacept will jointly design a global phase III clinical programme anticipated to begin in mid 2010 with the goal of filing a new drug application (NDA) with the US Food and Drug ...