- Friday, 13 November 2015
- TAGRISSO™ (osimertinib) (AZD9291) approved by the US FDA as treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO™ (osimertinib) (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
- Tuesday, 10 November 2015
- PEGASUS-TIMI 54 sub-analysis outlines long-term tolerability data for BRILINTA AstraZeneca today announced results of a sub-analysis of the PEGASUS-TIMI 54 study, which evaluated reasons and rates for discontinuation of BRILINTA® (ticagrelor) in patients with a history of myocardial infarction (MI) (one to three years prior to study randomization) and the efficacy in those patients who stayed on therapy.
- Monday, 9 November 2015
- AstraZeneca presents positive update on lesinurad renal data in gout patients AstraZeneca today announced positive subanalysis data of the Phase III lesinurad studies (CLEAR1, CLEAR2 and CRYSTAL) for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).
- Thursday, 5 November 2015
- AstraZeneca PLC third quarter and nine months results 2015 Visit our global site to view full details of the event.
- Friday, 23 October 2015
- FDA Advisory Committee recommends the approval of lesinurad for gout patients AstraZeneca today announced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The AAC reviewed safety and efficacy data from the pivotal Phase III combination therapy program trials, representing the largest clinical trial data set of gout patients treated with combination urate lowering therapy.
- Thursday, 8 October 2015
- AstraZeneca presents respiratory syncytial virus (RSV) study results at IDWeek 2015 In collaboration with physicians at 43 US hospitals, AstraZeneca today presented results from an ongoing observational study, SENTINEL1, at the IDWeek 2015 annual scientific meeting in San Diego, California. SENTINEL1 was designed to characterize RSV-confirmed hospitalizations among US preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis during the 2014-2015 RSV season.
- Wednesday, 30 September 2015
- SYMBICORT real-world study results published in the International Journal of COPD Results from a US comparative effectiveness study of two maintenance treatment options for patients with a history of chronic obstructive pulmonary disease (COPD) were published recently in the International Journal of COPD. This is the first US real-world study to examine the comparative effectiveness of SYMBICORT® 160/4.5 (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, an inhaled corticosteroid and long-acting beta2-agonist combination therapy, and tiotropium bromide 18 mcg, a long-acting muscarinic antagonist, in patients with COPD.
- Tuesday, 29 September 2015
- New dose of BRILINTA now available in US pharmacies AstraZeneca announced today that BRILINTA® (ticagrelor) 60-mg tablets are now available in US pharmacies. On September 3, 2015, the US Food and Drug Administration (FDA) approved a new 60-mg dosage strength for BRILINTA to be used in patients with a history of heart attack beyond the first year. BRILINTA is approved to reduce the rate of cardiovascular (CV) death, myocardial infarction ([MI], also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, BRILINTA is superior to clopidogrel. BRILINTA is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel at 12 months.
- Tuesday, 22 September 2015
- AstraZeneca to present data demonstrating diversity of its portfolio of innovative formulations and devices at the European Respiratory Society International Congress 2015 AstraZeneca will present 33 abstracts from across the respiratory disease portfolio at the 2015 European Respiratory Society (ERS) meeting in Amsterdam, Netherlands, 26-30 September. Data will include results from AstraZeneca’s growing inhaled portfolio of LAMA/LABA therapies, as well as findings from the company’s biologics pipeline and early science programs.
- Friday, 11 September 2015
- AstraZeneca purchases US biologics manufacturing facility to support growing pipeline AstraZeneca today added to its biologics manufacturing capability in the US with the purchase of a high-tech biologics bulk manufacturing facility from Amgen Inc. Over time, the LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the Company’s extensive portfolio of biologics medicines.
These press releases were issued in the United States (US) and are posted here as reference information for US investors and journalists only. The information contained in each press release was accurate at the time of issuance, and AstraZeneca assumes no responsibility for updating the information to reflect subsequent developments.
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