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
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Combination shows consistent benefit across prespecified post-progression outcomes
Pharma Solutions operates 10 research and development and/or production sites globally
Acquisition to further expand the Alexion, AstraZeneca Rare Disease pipeline beyond complement inhibition
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
The validations confirm the completion of the applications and commence the scientific review process
The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters
ANVISA issues CGMP to Concord Biotech’s Unit I
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