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

AstraZeneca plc (LON:AZN) Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with..

AstraZeneca AZD7442 to advance into two Phase III clinical trials

AstraZeneca plc (LON:AZN) long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are..

AstraZeneca’s Farxiga granted Breakthrough Therapy Designation in US

AstraZeneca’s Farxiga (dapagliflozin) has been granted Breakthrough Therapy Designation (BTD) in the US for patients with chronic kidney disease (CKD), with and without type-2 diabetes (T2D). CKD is a serious, progressive condition..

AstraZeneca appoints Dr Euan Ashley as a Non-Executive Director

AstraZeneca PLC (LON:AZN) has announced that with effect from 1 October 2020, Dr Euan Ashley is appointed as a Non-Executive Director and a member of the Science Committee. Euan Ashley..

AstraZeneca’s Lynparza recommended for EU marketing authorisation for ovarian cancer

AstraZeneca plc (LON:AZN) and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient..

AstraZeneca’s Fasenra phase III OSTRO trial met co-primary endpoints

High-level results from the OSTRO Phase III trial showed AstraZeneca plc (LON:AZN) Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in..

AstraZeneca’s Farxiga reduces CKD progression and risk of death

Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca plc (LON:AZN) Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal..

AstraZeneca Phase I clinical trial initiated for COVID-19 monoclonal antibody

AstraZeneca plc (LON:AZN) has confirmed that the first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the..

AstraZeneca’s Imfinzi granted FDA Priority Review for less-frequent, fixed-dose use

AstraZeneca plc (LON:AZN) Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose..

AstraZeneca Calquence recommended for approval in the EU

AstraZeneca plc (LON:AZN) Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common..

AstraZeneca’s Breztri Aerosphere approved in the US for COPD

AstraZeneca plc (LON:AZN) Breztri Aerosphere has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US Food and..

AstraZeneca’s Brilinta granted FDA Priority Review for stroke

AstraZeneca plc (LON:AZN) has announced the US Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for Brilinta for the reduction of subsequent stroke..

AstraZeneca’s Lynparza receives EU approval for pancreatic cancer

AstraZeneca plc (LON:AZN) and MSD Inc., Kenilworth, N.J., US (known as Merck & Co., Inc. inside the US and Canada) have announced that Lynparza has been approved in the European..

AstraZeneca’s selumetinib granted orphan drug designation in Japan

AstraZeneca plc (LON:AZN) has announced that selumetinib has been granted orphan drug designation in Japan for the treatment of neurofibromatosis type 1 (NF1), a rare and debilitating genetic disease.1 Selumetinib..

AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s COVID-19 vaccine

AstraZeneca plc (LON:AZN) has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the..

AstraZeneca Brilinta approved in the US by FDA

AstraZeneca PLC (LON:AZN) Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD),..

AstraZeneca Tagrisso demonstrates unprecedented disease-free survival

Detailed results from the Phase III ADAURA trial showed AstraZeneca PLC (LON:AZN) Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the adjuvant treatment of patients..

AstraZeneca Enhertu granted Orphan Drug Designation in the US for gastric cancer

AstraZeneca PLC (LON:AZN) and Daiichi Sankyo Company Limited’s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation in the US for the treatment of patients with gastric cancer, including gastroesophageal junction..

AstraZeneca concludes first agreements for University of Oxford’s potential new COVID-19 vaccine

AstraZeneca PLC (LON:AZN) is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s..

AstraZeneca Lynparza approved in the US by FDA for prostate cancer

AstraZeneca PLC (LON:AZN) and MSD Inc., Kenilworth, N.J., US today announced that Lynparza has been approved in the US for patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer...

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