News about "European Medicines Agency "

European Medicines Agency Launches Advisory Group to Tackle Vaccine Hesitancy

‘European Medicines’ Advisory Group aims to rebuild public trust, strengthen vaccine communication and counter misinformation across Europe.

European Medicines Agency | 02/05/2026 | By News Bureau

AbbVie Submits FDA Application for SKYRIZI Subcutaneous Induction in Crohn's Disease

AbbVie Inc. submits an application to the US Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) subcutaneous induction in Crohn’s disease, supported by Phase 3 AFFIRM data, offering a potential new treatment option.

European Medicines Agency | 29/04/2026 | By News Bureau

Soligenix Reports Phase 3 FLASH2 Interim Results for HyBryte in Cutaneous T-Cell Lymphoma

Soligenix reports Phase 3 FLASH2 interim results for HyBryte in Cutaneous T-Cell Lymphoma, with the study recommended for early termination due to futility.

European Medicines Agency | 29/04/2026 | By News Bureau

US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation

FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.

European Medicines Agency | 23/04/2026 | By News Bureau |  144

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 |  202

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 |  166

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 |  115