The CHMP recommends granting a marketing authorization to NVS' Fabhalta for the treatment of adults with C3 glomerulopathy, an ultra-rare, progressive kidney disease with no currently approved ...

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...

The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...

Krystal Biotech receives positive CHMP opinion recommending the approval of Vyjuvek for treating dystrophic epidermolysis bullosa in the EU.

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...

If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer ...

Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, ...

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.