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RSS FeedPosted by Michael Wonder on 20 Sep 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 18 Sep 2024
EMA publishes agenda for 16-19 September 2024 CHMP meeting
16 September 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Sep 2024
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
12 September 2024 - Janssen-Cilag today announced the submission of the marketing authorisation application to the EMA) seeking first approval ...
Posted by Michael Wonder on 11 Sep 2024
Pierre Fabre Laboratories receives European Commission approval for Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation
30 August 2024 - European approval is based on results from the Phase 2 PHAROS trial, which showed a meaningful ...
Posted by Michael Wonder on 11 Sep 2024
Eylea 8 mg pre-filled syringe approved in the EU
9 September 2024 - Germany will be one of the first markets to launch the new pre-filled syringe. ...
Posted by Michael Wonder on 06 Sep 2024
EMA Committee for Medicinal Products for Human Use adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-COV-2 variant JN.1
5 September 2024 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European ...
Posted by Michael Wonder on 06 Sep 2024
Advanz Pharma secures temporary suspension of the European Commission decision on the Ocaliva conditional marketing authorisation in Europe
5 September 2024 - Advanz Pharma today announces that the General Court of the European Union has temporarily suspended the European ...
Posted by Michael Wonder on 05 Sep 2024
Prilenia’s pridopidine for Huntington’s disease accepted for European marketing authorisation review
3 September 2024 - Prilenia Therapeutics announces the acceptance of its European marketing authorisation application for pridopidine (45 mg orally ...
Posted by Michael Wonder on 29 Aug 2024
European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
29 August 2024 - This follows approval in US, with other countries anticipated, including Japan later this year. ...
Posted by Michael Wonder on 29 Aug 2024
European Commission approves Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy
27 August 2024 - Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival ...
Posted by Michael Wonder on 28 Aug 2024
European Commission approves Astellas' Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced urothelial cancer
28 August 2024 - European marketing authorisation based on positive overall survival and progression-free survival results from the global Phase ...
Posted by Michael Wonder on 27 Aug 2024
Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
27 August 2024 - Approval is based on COMMODORE 2, where subcutaneous PiaSky once a month was equivalent to intravenous eculizumab ...
Posted by Michael Wonder on 27 Aug 2024
Sifi receives European Commission approval for Akantior
26 August 2024 - Akantior (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis. ...
Posted by Michael Wonder on 26 Aug 2024
Merck receives European Commission approval for Winrevair (sotatercept) in combination with other pulmonary arterial hypertension therapies, for the treatment of pulmonary arterial hypertension in adult patients with functional class II-III
26 August 2024 - Winrevair is the first activin signaling inhibitor therapy for pulmonary arterial hypertension approved in Europe. ...