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 […]
The European Medicines Agency (EMA), the EU’s drug regulator, has now approved a total of 52 new medicines for human use in the first seven months of the […]
The European Medicines Agency (EMA) has approved additional manufacturing capacity for the Pfizer/BioNTech COVID-19 vaccine in France – increasing production by 51 million doses by the end of […]
The European Medicine Agency’s key decision-making committee on human medicines (CHMP), has recommended eight medicines for approval at its June meeting. The Committee recommended granting a conditional marketing authorisation for Abecma […]
The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016, […]
The European Medicines Agency gave its backing to 15 new medicines at its December meeting, taking its total for the year to 96. This rounded off a busy […]
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