Countdown to launch of Europe’s new clinical trials system

Written by | 7 Sep 2021

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 […]

EU green light for more than 50 new drugs in 2021

Written by | 6 Sep 2021

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 […]

EU approval boosts COVID vaccine manufacturing capacity

Written by | 5 Sep 2021

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 […]

EMA gives green light for 8 new medicines

Written by | 17 Jul 2021

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 […]

EMA reports big wins for small pharma

Written by | 16 Jul 2021

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, […]

EU approved 96 new medicines in 2020

Written by | 14 Jan 2021

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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