Green light for new medicines in the EU
The European Medicines Agency (EMA) approved a total of 89 new medicines in 2022. Of these, 41 had a new active substance which had never been authorised in […]
The European Medicines Agency (EMA) approved a total of 89 new medicines in 2022. Of these, 41 had a new active substance which had never been authorised in […]
The European Medicines Agency (EMA) has approved four new medicines at its January meeting, getting 2023 off to a low-key start. The Agency’s key human medicines committee (CHMP) […]
The European Medicine Agency’s (EMA) key human medicines committee (CHMP) has recommended four medicines for approval at its November 2022 meeting. This brings to 84 the number of […]
The European Medicines Agency (EMA) has approved 12 new medicines at the September meeting of its key decision-making panel, the Committee on Human Medicinal Products (CHMP). The expert […]
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have recommended second booster doses of mRNA COVID-19 vaccines for people aged 60 […]
The European Medicines Agency (EMA) has recommended extending the use of Imvanex, a smallpox vaccine, for the prevention of monkeypox infection in adults. The news came as the […]
The European Medicines Agency (EMA) has backed a joint statement by global regulators calling for greater collaboration on the use of real-world evidence in regulatory decision-making. The potential […]
Two established diabetes medicines have been given the green light for use outside the EU – even when stored at higher temperatures – under the EU Medicines for […]
It is ‘too early’ to consider using a fourth dose of mRNA COVID-19 vaccines in the general population, according to the European Medicines Agency (EMA) and the European […]
The EU drug regulator, the European Medicines Agency (EMA), has a beefed-up budget for 2022 and plans to grow further in the years ahead. The watchdog’s Management Board […]
Thirteen new medicines were given the green light at the December meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings to […]
The clock is ticking down to the ‘go-live’ date for the EU’s new Clinical Trials Information System (CTIS) which will roll out on 31 January 2022. The European […]
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