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AstraZeneca meets primary endpoint for Enhertu phase II trial

High-level results from the positive registrational Phase II trial DESTINY-Gastric01 showed AstraZeneca (LON:AZN) and Daiichi Sankyo Company, Limited’s Enhertu, achieved a statistically significant and clinically meaningful improvement in objective response rate..

AstraZeneca Imfinzi and tremelimumab granted Orphan Drug Designation in the US

AstraZeneca (LON:AZN) Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma,..

AstraZeneca Lynparza granted Priority Review by FDA

AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (known as Merck & Co., Inc. inside the US and Canada) today announced that a supplemental New Drug Application for Lynparza has..

AstraZeneca to close Phase III STRENGTH trial for Epanova

Following the recommendation from an independent Data Monitoring Committee, AstraZeneca (LON:AZN) has decided to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) due to its low likelihood..

AstraZeneca’s Lynparza granted FDA Priority Review for PAOLA-1

AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) has today announced that a supplemental New Drug Application for..

AstraZeneca’s Lokelma approved in China

AstraZeneca (LON:AZN) has announced today that Lokelma has been approved in China for the treatment of adult patients with hyperkalaemia. The approval by the National Medical Products Administration (NMPA) was..

AstraZeneca’s Farxiga granted FDA Priority Review

AstraZeneca (LON:AZN) has today announced the US Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for Farxiga to reduce the risk of cardiovascular..

AstraZeneca announce FDA approval of Enhertu in the US

AstraZeneca (LON:AZN) and Daiichi Sankyo Company, have today announced that the US Food and Drug Administration has approved Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive..

AstraZeneca’s triple-combination therapy approved in China for patients with COPD

AstraZeneca (LON:AZN) today announced that budesonide/glycopyrronium/formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This is the first approval by the National Medical..

AstraZeneca sells commercial rights to Arimidex and Casodex

AstraZeneca (LON:AZN) today announced that it has agreed to sell the commercial rights to Arimidex and Casodex in a number of European, African and other countries1 to Juvisé Pharmaceuticals. The..

AstraZeneca completes agreement to divest its commercial rights to Seroquel

AstraZeneca (LON:AZN) has completed an agreement to divest its commercial rights to Seroquel and Seroquel XR in Europe and Russia to Cheplapharm Arzneimittel GmbH. Financial considerations Under the terms of..

AstraZeneca Imfinzi approved in China for the treatment of NSCLC

AstraZeneca (LON:AZN) has today announced that it has received marketing authorisation from China’s National Medical Products Administration for Imfinzi for the treatment of patients with unresectable, Stage III non-small cell..

AstraZeneca Lynparza approved in China for BRCA-mutated advanced ovarian cancer

AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the companies have received marketing authorisation from..

AstraZeneca sells commercial rights of Seroquel and Seroquel XR

AstraZeneca (LON:AZN) has agreed to sell the commercial rights to Seroquel and Seroquel XR in the US and Canada to Cheplapharm Arzneimittel GmbH. Seroquel and Seroquel XR, used primarily to..

AstraZeneca Imfinzi granted FDA Priority Review

AstraZeneca (LON:AZN) today announced that the US Food and Drug Administration has accepted a supplemental Biologics License Application and granted Priority Review for Imfinzi for the treatment of patients with..

AstraZeneca receive EU approval for Qtrilmet for the treatment of type-2 diabetes

AstraZeneca (LON:AZN) has announced that the European Commission (EC) has approved Qtrilmet modified-release tablets to improve glycaemic control in adults with type-2 diabetes. The approval is based on data from..

AstraZeneca FDA accepts regulatory submission for selumetinib

AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) has announced that the US Food and Drug Administration has..

AstraZeneca presents results from the positive Phase III TULIP 2 trial for anifrolumab

AstraZeneca (LON:AZN) has presented detailed results from the positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus..

AstraZeneca PLC Roxadustat pooled analyses: no increased CV risk

AstraZeneca (LON: AZN) and FibroGen Inc. have presented pooled efficacy and cardiovascular safety analyses from the pivotal Phase III programme assessing roxadustat for the treatment of patients with anaemia from..

AstraZeneca presented results from Phase III OLYMPUS and ROCKIES trials

AstraZeneca (LON:AZN) has presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin levels in non-dialysis-dependent and dialysis-dependent patients with anaemia from chronic..

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