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1247 News Found

Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management
Drug Approval | December 23, 2025

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management

Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial


Bayer wins Japan nod for finerenone in broad heart failure population
Drug Approval | December 23, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients


FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
Drug Approval | December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care


FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Drug Approval | December 23, 2025

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial


Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch
News | December 21, 2025

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026


Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease
Clinical Trials | December 21, 2025

Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease

SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers


EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease
Drug Approval | December 20, 2025

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD


Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Drug Approval | December 18, 2025

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A