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AstraZeneca PLC Fasenra granted US Orphan Drug Designation

AstraZeneca plc (LON:AZN) today announced that the US Food and Drug Administration has granted Orphan Drug Designation to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE). EoE is a..

AstraZeneca plc agrees to buy US FDA Priority Review Voucher from Sobi

AstraZeneca plc (LON:AZN) today announced that it has agreed to buy a US Food and Drug Administration Priority Review Voucher for a total cash consideration of $95m from a subsidiary..

AstraZeneca PLC Roxadustat approved in China for the treatment of anaemia

AstraZeneca (LON: AZN) today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the treatment of anaemia..

AstraZeneca PLC Update on the Phase III NEPTUNE trial

AstraZeneca plc (LON: AZN) today announced final overall survival results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an..

AstraZeneca PLC Farxiga met primary endpoint in landmark Phase III

Farxiga met primary endpoint in landmark Phase III DAPA-HF trial for the treatment of patients with heart failure DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor..

AstraZeneca plc appoints Michel Demaré to its Board of Directors

AstraZeneca plc (LON:AZN) today announced that, with effect from 1 September 2019, Michel Demaré is appointed as a Non-Executive Director and a member of the Audit Committee. Leif Johansson, Chairman..

AstraZeneca plc Calquence granted US Breakthrough Therapy Designation

AstraZeneca plc (LON:AZN) today announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for Calquence as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia,..

AstraZeneca plc Lynparza Phase III PAOLA-1 trial met primary endpoint

AstraZeneca plc (LON:AZN) and MSD Inc., known as Merck & Co., Inc. inside the US and Canada, today announced positive results from the Phase III PAOLA-1 trial in women with..

AstraZeneca PLC Tagrisso significantly improves overall survival

AstraZeneca plc (LON: AZN) today announced positive overall survival results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or..

AstraZeneca PLC Lynparza Phase III PROfound trial in HRR

AstraZeneca plc (LON: AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III..

AstraZeneca PLC Forxiga label updated with positive cardiovascular outcomes

AstraZeneca plc (LON:AZN) today announced that the European Commission has approved an update to the marketing authorisation for Forxiga to include positive cardiovascular outcomes and renal data from the Phase..

AstraZeneca PLC Update on US regulatory decision for Farxiga in type-1 diabetes

AstraZeneca plc (LON: AZN) today announced that the US Food and Drug Administration has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an..

AstraZeneca PLC Imfinzi granted US Orphan Drug Designation for small cell lung cancer

AstraZeneca (LON: AZN) has today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung..

AstraZeneca PLC Fasenra receives positive EU CHMP opinion

AstraZeneca plc (LON: AZN) has today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option..

AstraZeneca PLC Imfinzi improves overall survival at interim analysis

AstraZeneca plc (LON: AZN) has today announced positive overall survival results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer, a disease with significant..

AstraZeneca plc Lynparza approved in Japan for 1st-line maintenance therapy

AstraZeneca plc (LON:AZN) and MSD Inc., Kenilworth, N.J., US today announced that Lynparza has been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated advanced..

AstraZeneca PLC Bevespi Aerosphere approved by the Japanese

AstraZeneca plc (LON:AZN) today announced that Bevespi Aerosphere has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease. This..

AstraZeneca PLC Lynparza approved in the EU for 1st-line maintenance treatment

AstraZeneca plc (LON: AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) have today announced that the European Commission (EC)..

AstraZeneca PLC Calquence significantly prolonged the time patient live without disease progression

AstraZeneca plc (LON: AZN) has today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association Annual Congress in Amsterdam, showing Calquence..

AstraZeneca Calquence Phase III ELEVATE-TN trial meets primary endpoint

AstraZeneca plc (LON:AZN) today announced positive results from the Phase III ELEVATE-TN trial of Calquence(acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in..

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