News about "European Medicines Agency "

FDA Approves Waskyra Gene Therapy for Wiskott-Aldrich Syndrome

Fondazione Telethon announced that the US FDA has approved Waskyra (etuvetidigene autotemcel), a gene therapy for Wiskott-Aldrich Syndrome (WAS), marking a milestone in both science and clinical care. The approval offers new hope for patients living with this rare immunodeficiency disorder.

European Medicines Agency | 11/12/2025 | By Akanki |  104

EU Approves Insmed's BRINSUPRI, the First Treatment for Non-CF Bronchiectasis

The European Commission has approved BRINSUPRI as the first treatment for Non-Cystic Fibrosis Bronchiectasis, offering a new option for patients with this serious, progressive lung disease. The first-in-class DPP1 inhibitor was granted accelerated assessment by the EMA, reflecting its significant public health importance.

European Medicines Agency | 19/11/2025 | By Dineshwori |  143

EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats

Under the new system, medicine developers can receive joint scientific advice from EMA and national clinical and ethics experts. This coordinated approach aligns trial and regulatory requirements early, helping accelerate trial approvals and access to critical medicines.

European Medicines Agency | 18/11/2025 | By Dineshwori |  206

EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome

The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.

European Medicines Agency | 17/11/2025 | By Dineshwori |  103

Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab

Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).

European Medicines Agency | 24/09/2025 | By Dineshwori |  107

Sanofi and Regeneron's Dupixent Receives Positive CHMP Opinion

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab), jointly developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents in the EU.

European Medicines Agency | 22/09/2025 | By Dineshwori |  235

Pfizer and BioNTech's Updated COVID-19 Vaccine Secures EMA Nod, Awaits Final EU Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Pfizer- BioNTech's LP.8.1-adapted monovalent COVID-19 vaccine in the European Union.

European Medicines Agency | 28/07/2025 | By Dineshwori |  163

Novo Nordisk Expects EC Approval of Alhemo Label Update for Haemophilia in 2 Months

Novo Nordisk has received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for expanded Alhemo use in haemophilia without inhibitors.

European Medicines Agency | 26/07/2025 | By Dineshwori |  305

Evergreen Theragnostics Opens Phase II Small Cell Lung Cancer Clinical Trial in EU

The CCK2-VIEW trial uses 68Ga-EVG321, a peptide-based Radioligand imaging agent administered to patients with small cell lung cancer.

European Medicines Agency | 18/10/2024 | By Aishwarya |  479

EMA Approves Marketing Authorization Application of Nidlegy

Philogen and Sun Pharmaceutical Industries Ltd. have announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy.

European Medicines Agency | 05/07/2024 | By Aishwarya |  376