News about "European Medicines Agency "

STADA and Bio-Thera Secure EU Marketing Approval for Golimumab Biosimilar Gotenfia

European Commission authorises Gotenfia, referencing Simponi, for multiple autoimmune diseases across EU and EEA markets.

European Medicines Agency | 16/02/2026 | By News Bureau

J&J Wins CHMP Nod for AKEEGA in BRCA-Mutated mHSPC

Backed by positive AMPLITUDE trial results, the CHMP opinion supports AKEEGA in BRCA-mutated mHSPC, showing delayed disease progression and early signs of improved Overall Survival (OS) versus standard of care.

European Medicines Agency | 02/02/2026 | By News Bureau

European Commission Expands Bracco's Vueway Approval to Infants and Neonates

Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.

European Medicines Agency | 28/01/2026 | By News Bureau

Eisai Submits EMA Application for Once-Monthly Maintenance Dosing of Alzheimer's Drug Lecanemab

BioArctic partner Eisai has filed a Marketing Authorisation Variation with the EMA seeking approval for a once-every-four-weeks IV maintenance dosing regimen for lecanemab in early Alzheimer’s disease.

European Medicines Agency | 27/01/2026 | By News Bureau

Samsung Bioepis Launches BYOOVIZ Biosimilar in Europe

Samsung Bioepis has completed the transfer of BYOOVIZ commercial rights from Biogen, making it the company’s fourth biosimilar directly marketed in Europe, with a pre-filled syringe launch planned for Q2 2026.

European Medicines Agency | 03/01/2026 | By News Bureau

EMA Grants Accelerated Assessment to WCK 5222 by Wockhardt

The European Medicines Agency (EMA) has granted Accelerated Assessment status to Wockhardt’s WCK 5222, a fixed-dose combination of zidebactam and cefepime, following a pre-submission meeting—potentially enabling a faster regulatory review of the novel antibiotic therapy.

European Medicines Agency | 02/01/2026 | By News Bureau |  109

EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia

Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.

European Medicines Agency | 24/12/2025 | By News Bureau

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 |  175

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 |  190

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 |  244