Approval based on Phase III WINDWARD programme that demonstrated significant
reductions in asthma exacerbations, improvements in lung functionand reductions in
oral corticosteroid use from baseline, versus placebo
Fasenra is the first approved respiratory biologic with an 8-week maintenance dosing schedule
AstraZeneca and its global biologics research and development arm,
AstraZeneca announced today the publication of a new analysis from an ongoing real-world quality registry that suggests the risk of experiencing a repeat heart attack (also known as a myocardial infarction or MI) from occlusions in non-stentedarteries is twice as high as the risk stemming from the initially stented artery following a first heart attack.
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm),
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
Acceptance follows FDA Breakthrough Therapy Designation
Tagrisso granted Priority Review
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity agains
AstraZeneca, along with Acerta Pharma, its haematology research and development centre of excellence, and MedImmune, its global biologics research and development arm, will highlight significant progress in blood cancer research at the 59th 2017 American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
AstraZeneca today announced that the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib),
AstraZeneca today announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster.
AstraZeneca today announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib).
Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival (PFS)
Second approval in three months expands treatment options for women with HR+, HER2- advanced breast cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for
Faslodex (fulvestrant), expanding the indication to include use with
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
