News about "European Medicines Agency "

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

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

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

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 192

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

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 213

EMA Approves Marketing Authorization Application of Nidlegy

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 279

EMA Approves Dupixent as First-Ever Targeted Therapy for Patients with COPD

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 324


 

 

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