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Results For "European-Medicines-Agency"

242 News Found

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
News | January 01, 2026

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva
Drug Approval | May 04, 2026

Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva

Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market


GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push
News | April 30, 2026

GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push

The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need


Moderna wins EU approval for first combined flu & COVID shot for adults 50+
Drug Approval | April 22, 2026

Moderna wins EU approval for first combined flu & COVID shot for adults 50+

The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states


EMA gives green light to warmer & simpler delivery rules for Wegovy injection
News | April 12, 2026

EMA gives green light to warmer & simpler delivery rules for Wegovy injection

Novo Nordisk continues to position Wegovy as a cornerstone of its obesity treatment portfolio


EU nod to Rezurock for chronic GVHD in adults & teens
News | April 08, 2026

EU nod to Rezurock for chronic GVHD in adults & teens

Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation


EMA moves to cut animal testing with “virtual control groups” in preclinical research
Policy | April 03, 2026

EMA moves to cut animal testing with “virtual control groups” in preclinical research

The approach, which could significantly reduce the number of rats used in certain dose-range finding studies