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www.ema.europa.eu EMA’s Patients and Consumer Working Party (PCWP) has elected Marco Greco of the European Patients Forum as its new co-chair. The Healthcare Professionals’ Working Party (HCPWP)…, Marco Greco is a lawyer by training and has extensive advocacy experience. He is a...
www.ema.europa.eu The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to make the European Union (EU) a more attractive destination for clinical research and improve...
www.ema.europa.eu As included in the product information for paracetamol in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of malformations in the developing foetus or in newborns.In 2019, EMA reviewed available studies that...
www.ema.europa.eu EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These guidelines will support the implementation of the new Variations Regulation that came into force in January...
www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of Uplizna (inebilizumab) to include the treatment of adult patients with active immunoglobulin G4-related disease (IgG4-RD).IgG4-RD is a rare, chronic, autoimmune condition (a...
www.ema.europa.eu 14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.The committee recommended granting a marketing authorisation for Enflonsia (clesrovimab), a medicine indicated for the...