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Results For "European-Medicines-Agency"

257 News Found

Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Drug Approval | December 18, 2025

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU


EMA backs Eylea 8 mg for retinal vein occlusion
News | December 13, 2025

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial


Merck wins key EU backing to expand use of PAH Drug WINREVAIR
News | December 13, 2025

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states


Pfizer’s therapy scores major win in Phase 3 trial for Hemophilia patients with inhibitors
Clinical Trials | December 08, 2025

Pfizer’s therapy scores major win in Phase 3 trial for Hemophilia patients with inhibitors

HYMPAVZI’s safety profile was generally favorable


Praxis Precision hits milestone in fight against rare paediatric seizures
Clinical Trials | December 08, 2025

Praxis Precision hits milestone in fight against rare paediatric seizures

The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies


Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome
Biopharma | December 04, 2025

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor


AbbVie’s Atogepant shows breakthrough results for acute migraine relief
Clinical Trials | December 03, 2025

AbbVie’s Atogepant shows breakthrough results for acute migraine relief

Suffering from acute migraine? You may soon bid adieu to the debilitating headache