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. The European Medicines Agency (EMA) in late January said the European Commission had requested a review of additional safety information for the drug,

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 ...

Gilead Sciences has announced EMA validation for a parallel accelerated review of lenacapavir’s MAA and EU-M4all applications.

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.

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

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.