The European Union’s medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen’s Alzheimer’s ...

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 ...

First chikungunya vaccine approved in Europe for persons as young as 12 years old.On track for launch in key European markets in the first half of 2025. COPENHAGEN, Denmark, February 28, 2025 ...

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

Recommendation based on the findings from the Phase 3 QUASAR programme in ulcerative colitis 1. Beerse, Belgium (28 February 2025) - Johnson & Johnson today announced that the Com ...

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, ...