AstraZeneca today announced positive overall survival (OS) 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 metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced positive results from the Phase III PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a *homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).
AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.
Fortsatt stark produktförsäljning styrker förtroendet för hållbar tillväxt Tillväxten i produktförsäljning under första halvåret på 12% (17% i fasta valutakurser1) till 11 183 MUSD innefattar en försäljningsacceleration under andra kvartalet till 5 718 MUSD (+14%, +19% i fasta valutakurser). Under andra kvartalet levererade alla försäljningsregioner och samtliga tre terapiområden goda resultat.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control.
AstraZeneca 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 cancer (SCLC).
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial.
AstraZeneca 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 for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European Union.
AstraZeneca today announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients.
AstraZeneca today announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).
AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that Lynparza (olaparib) has been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated (BRCAm) advanced ovarian cancer, as detected by an approved companion diagnostic test.
AstraZeneca today announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
