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AstraZeneca and MSD’s Lynparza approved in the EU for prostate cancer

AstraZeneca plc (LON:AZN) and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer..

AstraZeneca granted PDUFA extension to allow further time for a full review on Lynparza

AstraZeneca plc (LON:AZN) and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date..

AstraZeneca to sell its West Chester site to National Resilience

AstraZeneca plc (LON:AZN) has announced the sale of its West Chester site in Ohio, US, to National Resilience, Inc., a technology-focused manufacturing company dedicated to broadening access to complex medicines...

AstraZeneca’s Imfinzi recommended for approval in EU for BTC

AstraZeneca plc (LON:AZN) Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer..

AstraZeneca’s Imfinzi with Imjudo approved in the US for NSCLC

AstraZeneca plc (LON:AZN) Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small..

AstraZeneca receives recommendation from FDA Committee for PT027 in asthma

AstraZeneca plc (LON:AZN) has announced that PT027 has been recommended by FDA advisory committee as new rescue treatment for asthma. The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee..

AstraZeneca’s Capivasertib could become first-in-class treatment option for HR-positive breast cancer

Positive high-level results from the CAPItello-291 Phase III trial showed that AstraZeneca plc (LON:AZN) capivasertib in combination with Faslodex (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in progression-free..

AstraZeneca Alexion’s Ultomiris approved in Europe for gMG

AstraZeneca plc (LON:AZN) has announced that Ultomiris (ravulizumab) has been approved in Europe as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG)..

AstraZeneca’s Beyfortus recommended for approval in the EU by CHMP

AstraZeneca plc (LON:AZN) and Sanofi’s Beyfortus (nirsevimab) has been recommended for marketing authorisation in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease..

AstraZeneca’s Forxiga approved in China for CKD

AstraZeneca plc (LON:AZN) Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney..

AstraZeneca’s Farxiga reduced risk of cardiovascular death in trial

Detailed results from the DELIVER Phase III trial showed AstraZeneca plc (LON:AZN) Farxiga (dapagliflozin) significantly reduced the composite of cardiovascular (CV) death or worsening heart failure (HF) in patients with..

AstraZeneca’s Lynparza granted FDA priority review for PROpel

AstraZeneca plc (LON:AZN) supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for..

AstraZeneca DESTINY-Breast02 Phase III trial of Enhertu met the primary endpoint

AstraZeneca plc (LON:AZN) has announced that positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu (trastuzumab deruxtecan) versus physician’s choice of treatment showed the trial met the primary..

AstraZeneca completes acquisition of TeneoTwo

AstraZeneca plc (LON:AZN) has completed the acquisition of TeneoTwo, Inc.i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma.1 AstraZeneca..

AstraZeneca’s Enhertu approved in the US for HER2-low metastatic breast cancer

AstraZeneca plc (LON:AZN) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC..

AstraZeneca’s Lynparza approved in EU for early breast cancer

AstraZeneca plc (LON:AZN) and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients..

AstraZeneca appoints Michel Demaré as the Chair-designate of the Board

AstraZeneca PLC (LON:AZN) has announced the appointment of Michel Demaré as the Chair-designate of the Board. His appointment followed a robust succession planning process led by Philip Broadley in his..

AstraZeneca’s Tezspire recommended for marketing authorisation in the EU

AstraZenec plc (LON:AZN) Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who..

AstraZeneca’s Enhertu approved in the EU for HER2-positive mBC

AstraZeneca plc (LON:AZN) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic..

AstraZeneca to acquire TeneoTwo and its clinical-stage T-cell engager

AstraZeneca plc (LON:AZN) has announced an agreement to acquire TeneoTwo, Inc.i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma1...

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