The European Commission has approved Merck’s Erbitux BRAF V600E mCRC combination regimen cetuximab plus encorafenib and FOLFOX as first-line therapy for metastatic colorectal cancer with the BRAF V600E mutation, based on Phase 3 BREAKWATER data showing a 51% reduction in risk of death versus standard chemotherapy.
The recent Hympavzi European Commission Approval marks a milestone for the hemophilia community, introducing the first once-weekly anti-TFPI therapy for patients with inhibitors in the EU.
Johnson & Johnson secures EC approval for AKEEGA® as the first precision-medicine combo for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by landmark rPFS data from the AMPLITUDE trial.
European Commission approves Wegovy 7.2 mg for obesity treatment. Clinical trial shows 21% average weight loss with 84% from fat mass. Now available across EU.
Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.
The European Commission (EC) has granted a landmark approval for Johnson & Johnson’s DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma (SMM). This decision marks a significant shift in the treatment paradigm for this precursor to active multiple myeloma, moving away from the traditional “watch and wait” approach to proactive, early therapeutic intervention.
The European Commission has approved AstraZeneca’s Imfinzi, establishing a new standard of care for muscle-invasive bladder cancer. This landmark decision makes Imfinzi the first perioperative immunotherapy available to patients in the EU, following a pivotal Phase III trial where the regimen significantly reduced the risk of cancer recurrence and death. This approval marks a transformative moment for patients with this high-risk disease.
Novo Nordisk announced that its leading diabetes medication, Ozempic® (semaglutide), has received a positive recommendation in the EU for an updated label to include peripheral arterial disease.
AstraZeneca’s Calquence-based fixed-duration regimens gain EU approval for treating first-line CLL, offering patients a powerful, time-limited alternative to traditional continuous therapy.
The UK announced its decision to associate with Horizon Europe and Copernicus programmes through a new agreement with the European Union (EU).
