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www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Imdylltra (tarlatamab) as monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with platinum-based...
www.ema.europa.eu Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting. The committee recommended granting a conditional marketing authorisation for Adstiladrin (nadofaragene firadenovec), for...
www.ema.europa.eu EMA’s committee for human medicines, CHMP, has recommended that Tecovirimat SIGA should no longer be used for the treatment of mpox. This recommendation does not affect the other authorised uses of Tecovirimat SIGA, which include the treatment of smallpox, cowpox and...
www.ema.europa.eu EMA launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. After the completion of a two-year pilot, the Agency has integrated these additional tools to support continued...
www.ema.europa.eu EMA annual report 2025 The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for AviGate S. Infantis, for active immunisation of healthy chickens to reduce faecal excretion and colonisation of internal organs with Salmonella...