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News about "European Medicines Agency "
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
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 | 177
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 | 137
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 | 266
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 | 341
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 | 346
EMA Approves Dupixent as First-Ever Targeted Therapy for Patients with COPD
The European Medicines Agency (EMA) has recently announced their approval for Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
European Medicines Agency | 04/07/2024 | By Aishwarya | 379
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