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RSS FeedPosted by Michael Wonder on 28 Jun 2025
Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 27 Jun 2025
Philogen provides update on marketing authorisation application for Nidlegy in the European Union
24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...
Posted by Michael Wonder on 25 Jun 2025
Linerixibat accepted for review by the EMA for cholestatic pruritus in patients with primary biliary cholangitis
23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial ...
Posted by Michael Wonder on 14 Jun 2025
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older
13 June 2025 - Regulatory decision anticipated H1, 2026. ...
Posted by Michael Wonder on 03 Jun 2025
MaaT Pharma submits marketing authorisation application to the EMA for Xervyteg (MaaT013) in acute graft versus host disease
2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...
Posted by Michael Wonder on 03 Jun 2025
Zealand Pharma submits marketing authorisation application to the EMA for glepaglutide in short bowel syndrome
2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...
Posted by Michael Wonder on 29 May 2025
Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
Posted by Michael Wonder on 23 May 2025
Soleno Therapeutics announces submission and EMA validation of marketing authorisation application for diazoxide choline prolonged release tablets for the treatment of hyperphagia in patients with Prader-Willi syndrome
22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release ...
Posted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 09 Apr 2025
Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU
8 April 2025 - Bayer has submitted an application to the EMA seeking approval of aflibercept 8 mg (114.3 mg/ml solution ...
Posted by Michael Wonder on 04 Apr 2025
Helsinn submits a new formulation of Akynzeo to the EMA
2 April 2025 - Helsinn today announced the submission of a new formulation for Akynzeo to the EMA. ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 30 Mar 2025
EMA validates Henlius and Organon filing for Perjeta (pertuzumab) biosimilar candidate HLX11
28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for ...
Posted by Michael Wonder on 28 Mar 2025
Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly
27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...