News about "European Medicines Agency "

Abbisko's Irpagratinib Secures EMA Orphan Drug Tag for Liver Cancer

European regulator grants rare disease designation to FGFR4 inhibitor, boosting its clinical development and commercial prospects in hepatocellular carcinoma.

European Medicines Agency | 01/04/2026 | By News Bureau

EU Grants Conditional Approval to Rezurock for Chronic GVHD Treatment

European Commission authorises belumosudil for patients aged 12 plus with limited treatment options, marking a significant advance in managing a life-threatening post-transplant condition.

European Medicines Agency | 01/04/2026 | By News Bureau

EMA Expands PRIME Programme with New Tools to Accelerate Drug Development

EMA introduces three new features to its PRIME scheme, enhancing regulatory support, speeding scientific advice, and improving readiness for marketing authorisation submissions.

European Medicines Agency | 21/03/2026 | By News Bureau

Ipsen receives positive EMA panel opinion for Ojemda to treat paediatric low-grade glioma

European Medicines Agency’s CHMP recommends conditional approval of Ojemda (tovorafenib) for children with BRAF-altered paediatric low-grade glioma, offering a potential targeted therapy option for relapsed or refractory cases.

European Medicines Agency | 05/03/2026 | By News Bureau |  171

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 |  126

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 |  111

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 |  120

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 |  227