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  • Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.The committee recommended…, CHMP statistics Key figures from the June 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Aujemflu Common name Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture) Marketing authorisation applicant Seqirus Netherlands…, Hopledo INN levodopa / carbidopa  Marketing authorisation applicant Zambon S.p.A. Therapeutic indication Treatment of adult patients with Parkinson’s…, Onswik INN insulin efsitora alfa  Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of type […]
  • CVMP opinions on veterinary medicinal productsThe Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as…
  • Crisis preparedness and responseThe Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and…
  • PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent  Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
  • Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important…
  • EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO…
  • June is PRIDE month and EMA starts a two-month celebration of diversity and inclusion in science and healthcare, leading up to its participation in the world-famous Amsterdam…, Our strength in the EU comes from our unity in diversity. Equality and non-discrimination are critical everywhere, but in health they can make the difference between…, EMA staff will be joined on the boat by representatives of patient organisations such as EURORDIS-Rare Diseases Europe, European AIDS Treatment Group (EATG) and the European…
  • EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant XFG for the 2026/2027 vaccination campaign.XFG is part of the…