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www.ema.europa.eu Second, we will intensify our support for innovation for public and animal health. We will further enhance our early development support to enable new medicines to be authorised in the EU as rapidly as possible. Third, we will continue to invest in our staff and build the...
www.ema.europa.eu The Management Board opened its meeting welcoming the political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the new EU pharmaceutical legislation. The legislation represents a historic milestone for...
www.ema.europa.eu EMA's office is closed from 18:00 on Monday 22 December 2025 to 08:30 on Monday 5 January 2026. Outside of working hours and on public holidays, it is possible to call our product emergency hotline on +31(0)88 781 7600. Please note that this is an emergency number and...
www.ema.europa.eu Seven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting. The committee recommended granting a conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept),...
www.ema.europa.eu EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and...
www.ema.europa.eu The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and procedures which have been introduced by different pieces of legislation over the years, namely the existing...