The European Union’s medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen’s Alzheimer’s drug, Leqembi, after concluding a safety review.

Vertex Pharmaceuticals (NASDAQ:VRTX) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed its twice-daily cystic fibrosis medication Kaftrio to a new patient group,

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

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM).

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a

The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...

With the European Medicines Agency identifying shortages in more than 30 critical medicines, the single market presents an opportunity to rethink

The latest announcement follows the recent US Food and Drug Administration (FDA) acceptance of the company’s new drug applications for lenacapavir for PrEP. The EMA's Committee

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

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

Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST]