Archive

Green light for four new medicines in the EU

Written by | 9 Mar 2025

The European Medicines Agency (EMA) has recommended four new products for approval, and extended the use of sixteen other drugs. The decisions, which brings to 12 the total […]

EMA approves 17 medicines at December meeting

Written by | 28 Dec 2024

The European Medicines Agency rounded off a busy year by approving seventeen new medicines. At its December meeting, the Committee for Medicinal Products for Human Use (CHMP) also […]

EU drug regulators agree common approach to data transparency

Written by | 27 Dec 2024

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and […]

EU approved 114 medicines in 2024

Written by | 26 Dec 2024

The European Medicines Agency has approved more than 100 new medicines for the first time in fifteen years. Of the 114 medicines given the green light in 2024, […]

EU drug watchdog rewrites conflict of interest rules

Written by | 4 Nov 2024

The European Medicines Agency (EMA) is revising its ‘competing interests’ policy for experts and members of scientific committees. The new rules are expected to be adopted by the […]

EU aims to make medicines review more efficient

Written by | 3 Nov 2024

The European Medicines Agency (EMA) and the European medicines regulatory network plan to improve the efficiency of how new medicines are assessed and approved. A new initiative aims […]

Green light for 10 new medicines in the EU

Written by | 2 Nov 2024

Ten new medicines have been recommended for approval by the European Medicines Agency (EMA), with another six products recommended for extension of their therapeutic indications. This brings to […]

European watchdog to support African drug regulator

Written by | 7 Sep 2024

The EU medicines regulator, the European Medicines Agency (EMA), has announced plans to support its counterparts in African countries – paving the way for the creation of a […]

New EU plan to boost orphan medical devices

Written by | 6 Sep 2024

The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU). The initiative offers […]

EU gives green light for 14 new medicines

Written by | 5 Sep 2024

The European Medicines Agency (EMA) has approved fourteen new medicines at a summer meeting, with a further eleven products recommended for extension of therapeutic indications. The Agency’s human […]

Green light for 12 new medicines from EU watchdog

Written by | 8 Apr 2024

The European Medicines Agency (EMA) has recommended the approval of twelve new products, following reviews by its key human medicines committee (CHMP). This brings to twenty-five the number […]

EU recommendations for seasonal flu vaccine composition

Written by | 7 Apr 2024

The winter flu season may be over in the northern hemisphere, but EU regulators are already looking ahead to the next outbreak in autumn 2024. Influenza viruses continuously […]

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