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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..

AstraZeneca divests rights to Seroquel and Seroquel XR in Europe and Russia

AstraZeneca (LON:AZN)has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm..

AstraZeneca Patients to benefit from further pipeline progress

AstraZeneca (LON:AZN) announced its year-to-date and Q3 2019 results. Year-to-date Product Sales growth of 13% (17% at CER1) to $17,315m included third-quarter Product Sales of $6,132m (+16%, +18% at CER)...

AstraZeneca Farxiga approved in the US by FDA

AstraZeneca (LON:AZN) announced that the US Food and Drug Administration has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes and..

AstraZeneca Trastuzumab deruxtecan granted FDA Priority Review

AstraZeneca (LON:AZN) and Daiichi Sankyo Company Limited announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201)..

AstraZeneca PLC Fasenra approved in the US for self-administration

Fasenra is now the only respiratory biologic that offers the choice of administration at home or in a doctor’s office with eight-week maintenance dosing AstraZeneca plc (LON: AZN) has today..

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