Tezspire approved in the EU for the treatment of severe asthma
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations AstraZeneca’s Tezspire( tezepelumab) has been approved…
Category Regulatory
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GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease
GSK plc( LSE/ NYSE GSK) moment blazoned that the US Food and Drug Administration( FDA) will convene a meeting of the Cardiovascular and Renal medicines…
Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer
Approval based on TOPAZ-1 Phase III trial results, which showed Imfinzicombination reduced risk of death by 20% vs. chemotherapy alone AstraZeneca’s Imfinzi( durvalumab) has been…
FDA Approves Spesolimab-Sbzo Injection for GPP Flares in adults
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares…
Kerendia™ (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
U.S. Food and Drug Administration (FDA) granted label update for Kerendia™ (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in…
FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease
Moment, theU.S. Food and Drug Administration approved Xenpozyme( Olipudase alfa) for intravenous infusion in pediatric and adult cases with Acid Sphingomyelinase Deficiency( ASMD), a rare…
Evusheld long- acting antibody combination approved for forestallment and treatment of COVID- 19 in Japan
First global blessing for Evusheld as a COVID- 19 treatment PROVENT Phase III forestallment trial showed reduced threatof developing characteristic COVID- 19 paraphernalia Phase III…
FDA Allows priority review to efanesoctocog alfa for people with hemophilia A
FDA grants priority review to efanesoctocog alfa for people with hemophilia A The FDA decision date for efanesoctocog alfa, an investigational factor VIII therapy, is set for February 28, 2023 Priority…
European Commission grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD)
Teva Pharmaceuticals to commercialize the product in Europe Age-related macular degeneration (AMD) affects around 67 million people in Europe and is a leading cause of…
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol),100mL Single Patient Use Glass Fliptop Vial; lot EA7470,…
First HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease AstraZeneca…
Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment…