European regulators have recommended extending TRYNGOLZA to adults with fasting triglycerides of at least 880 mg/dL. The decision follows two Phase 3 trials demonstrating substantial triglyceride reductions and 85% fewer adjudicated acute pancreatitis events in a pooled analysis.
Guardant360 CDx gains European CE marking for ETCAMAH patient selection. See how ESR1 blood testing changes advanced breast cancer treatment.
NewAmsterdam Pharma Company N.V. and Menarini Group have secured European marketing authorisations for Ubeslo and Evlarco, turning obicetrapib into a commercial-stage cholesterol therapy while leaving PREVAIL to answer the more consequential question of whether its LDL reductions translate into fewer cardiovascular events.
European regulators have approved AstraZeneca’s Trixeo Aerosphere for uncontrolled asthma from age 12 regardless of recent exacerbation history, potentially widening a respiratory franchise that generated $699 million in first-half 2026 sales.
The European Commission has approved Rinvoq for active polyarticular juvenile idiopathic arthritis in children aged two and older, adding another patient population to AbbVie’s rapidly growing immunology franchise and introducing a weight-based oral solution for younger patients.
The European Commission has approved Roche’s Susvimo implant for neovascular age-related macular degeneration, offering continuous ranibizumab delivery with refills every six months and creating a fundamentally different alternative to repeated eye injections.
European regulators have backed once-weekly Sogroya for children with idiopathic short stature, potentially giving Novo Nordisk the first EU-approved growth hormone specifically for the condition while expanding a rare-endocrine franchise beyond growth hormone deficiency.
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.
Europe has approved teclistamab plus daratumumab after MajesTEC-3 showed an 83.4% reduction in progression or death and a significant overall-survival advantage versus established regimens.
EU approval moves TECVAYLI plus daratumumab into earlier multiple myeloma treatment after Phase 3 data cut progression risk by 83.4%.