“We are thrilled by the positive CHMP opinion in support of expanding the Kaftrio in combination with ivacaftor indication to include all CF patients 2 years and older who make CFTR protein,” said ...

The CHMP recommends conditional marketing authorization of REGN's linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatmen ...

The European Commission (EC) has authorised the marketing of Bavarian Nordic's Vimkunya - the first chikungunya vaccine ...

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 ...

AbbVie ABBV announced that it has entered into a licensing agreement with Denmark-based biotech Gubra for the latter’s ...

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

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

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

Imfinzi in combination with chemotherapy has been recommended for approval in the European Union for the treatment of ...

Eisai (ESAIY) and Biogen (BIIB) announced that the Therapeutic Goods Administration, TGA, of Australia has confirmed the initial decision to ...

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 ...