Developed by Johnson & Johnson, guselkumab (GUS) is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said on Friday that the European Medicines Agency (EMA) endorsed ENHERTU for the ...

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

European Union's human medicines committee (CHMP) said on Friday it is not updating its opinion on Eisai and Biogen's ...

AbbVie (NYSE:ABBV) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their ...

The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...

| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...

During the EU Regulatory Town Hall, Emer Cooke, Executive Director of the EMA, will join María Jesús Lamas Díaz, Executive Director of the Spanish Agency for Medicines and Medical Devices (AEMPS), and ...