FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC

19 January 2022 - Regulatory filing recently submitted in the European Union. ...

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COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...

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Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity

14 January 2022 -  Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...

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Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency

13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...

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Accelerating clinical trials in the EU: for better clinical trials that address patients’ need

13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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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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