Drug Approval | April 02, 2024
AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Application based on results from the TROPION-Breast01 Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
Yesafili, received marketing authorization approval from the European Commission for the European Union
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
The partnership is part of BioNTech’s strategy to develop novel prophylactic vaccines for the prevention of high-medical-need infectious diseases
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