Blog
RSS FeedPosted 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
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 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. ...
Posted by Michael Wonder on 26 Aug 2024
Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
26 August 2024 - Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Balversa (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
23 August 2024 - Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Celltrion’s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for the treatment of multiple chronic inflammatory diseases
25 August 2024 - The European Commission approval is based on the totality of evidence including the results from a Phase ...
Posted by Michael Wonder on 21 Aug 2024
EMA publishes agenda for 19-22 August 2024 CHMP meeting
19 August 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Aug 2024
European Commission grants second indication approval for Tepkinly (epcoritamab) for the treatment of adults with relapsed/refractory follicular lymphoma
20 August 2024 - AbbVie today announced that the European Commission has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...