19 January 2022 - Regulatory filing recently submitted in the European Union. ...
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
14 January 2022 - Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...
10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...
10 January 2021 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...
20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...
31 December 2021 - Paion today announces that it has submitted an extension application to the marketing authorisation for remimazolam ...