USFDA grants priority review to AstraZeneca-Daiichi Sankyo Enhertu for HER2-low, HER2 Ultralow Breast Cancer Ruchika Sharma3 Oct 2024 9:15 AM ISTAstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and...
Daiichi Sankyo, AstraZeneca Enhertu gets USFDA breakthrough therapy designation for certain patients with HER2 low or HER2 ultralow metastatic breast cancer Ruchika Sharma21 Aug 2024 3:37 PM ISTTokyo: ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable...
AstraZeneca-Daiichi Sankyo Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer Ruchika Sharma15 Aug 2024 10:30 AM ISTCambridge: AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for...
USFDA issues complete response letter for Patritumab Deruxtecan in EGFR-Mutated NSCLC: Merck, Daiichi Sankyo Ruchika Sharma28 Jun 2024 10:00 AM ISTRahway: The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA)...
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA accelerated nod for metastatic HER2-positive solid tumours Ruchika Sharma7 April 2024 11:30 AM ISTCambridge: AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients...
AstraZeneca, Daiichi Sankyo Datopotamab deruxtecan application accepted in US for pretreated metastatic HR-positive, HER2-negative breast cancer Ruchika Sharma3 April 2024 12:30 PM ISTAstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the...
EMA validates marketing authorisation applications for AstraZeneca, Daiichi Sankyo datopotamab deruxtecan in lung, breast cancer Ruchika Sharma6 March 2024 3:25 PM ISTCambridge: The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s...
AstraZeneca-Daiichi Sankyo application for Datopotamab deruxtecan accepted in US for patients with previously treated advanced nonsquamous non-small cell lung cancer Ruchika Sharma19 Feb 2024 4:30 PM ISTCambridge: AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US...
Merck seeks more deals to prepare for Keytruda revenue decline Ruchika Sharma4 Feb 2024 12:30 PM ISTMerck & Co on Thursday said it was in the market for deals of up to around $15 billion as it plans for a loss of revenue from its aging cancer...
AstraZeneca Enhertu granted priority review in US for metastatic HER2-positive solid tumours Ruchika Sharma31 Jan 2024 12:45 PM ISTCambridge: AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been...
Esperion, Daiichi Sankyo Europe announce USD 125 million amendment to their collaboration, including resolution of pending litigation Ruchika Sharma4 Jan 2024 4:45 PM ISTAnn Arbor: Esperion Therapeutics, Inc. and Daiichi Sankyo Europe GmbH (DSE), the European headquarter organization of the Japanese pharmaceutical...
Trastuzumab deruxtecan: AstraZeneca India Pharma unveils HER-2 positive metastatic breast cancer therapy Ruchika Sharma3 Jan 2024 3:59 PM ISTNew Delhi: AstraZeneca India Pharma Ltd., a science-led biopharmaceutical company officially launched Trastuzumab deruxtecan, therapy tailored...
