Adam

Advancing regulatory science in the EU – new strategy adopted

EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support […]

Update on treatments and vaccines against COVID-19 under development

Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority to help save lives during the pandemic. Over recent weeks and months, the Agency has engaged with many developers of therapeutic medicines and there are a number of developments underway. However, at this point, on […]

Consolidated financial statement of the Eurosystem as at 27 March 2020

In the week ending 27 March 2020 the decrease of EUR 111 million in gold and gold receivables (asset item 1) reflected mainly the sale of gold by one Eurosystem central bank for the purpose of issuing commemorative gold coins. The net position of the Eurosystem in foreign currency (asset items 2 and 3 minus liability items 7, 8 and 9) […]

New gene therapy to treat spinal muscular atrophy

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. There are currently limited treatment options for children with […]