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Results For "European-Medicines-Agency"

222 News Found

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


Novo Nordisk fast-tracks higher-dose obesity drug to FDA
Clinical Trials | November 27, 2025

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway


Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi
Drug Approval | November 24, 2025

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis


Cosmo and Glenmark receives market authorization of Winlevi in Europe
News | November 23, 2025

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris


EMA launches streamlined process to fast-track critical medicines, vaccines
News | November 21, 2025

EMA launches streamlined process to fast-track critical medicines, vaccines

The move is expected to be crucial during health crises