Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant

11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...

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European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years

11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...

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European Commission approves Lumykras (sotorasib) for patients with KRAS G12C mutated advanced non-small cell lung cancer

10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...

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SIGA Technologies receives approval from the European Medicines Agency for tecovirimat

10 January 2021 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...

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EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19

10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...

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AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA

7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...

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Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS

4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...

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Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome

20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...

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Paion submits extension application of marketing authorisation for remimazolam in the indication general anaesthesia to the European Medicines Agency

31 December 2021 - Paion today announces that it has submitted an extension application to the marketing authorisation for remimazolam ...

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Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen

28 December 2021 - Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression ...

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Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA

23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...

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Helsinn Group announces EMA acceptance for review of the marketing authorisation application for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangements

21 December 2021 - Helsinn today announced that the EMA accepted for review the Company’s marketing authorisation application for infigratinib for ...

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EMA recommends Nuvaxovid for authorisation in the EU

20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...

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EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency

17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...

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Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus

20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...

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