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RSS FeedPosted by Michael Wonder on 25 Jun 2019
Nabriva Therapeutics announces EMA validation of marketing authorisation application for lefamulin
24 June 2019 - Nabriva Therapeutics today announced that the EMA has determined that the company’s marketing authorisation application for the ...
Posted by Michael Wonder on 24 Jun 2019
European Medicines Agency accepted first "China-Developed" biosimilar - Henlius HLX02 marketing authorisation application for review
21 June 2019 - First China-developed trastuzumab biosimilar accepted for MAA review by the EMA. ...
Posted by Michael Wonder on 11 Jun 2019
Evolus provides update of Nuceiva marketing authorisation application in Europe
10 June 2019 - Evolus today provided an update on the marketing authorisation application for Nuceiva in Europe that may ...
Posted by Michael Wonder on 06 Jun 2019
US FDA and EMA accept applications for ozanimod for the treatment of relapsing forms of multiple sclerosis
6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 05 Jun 2019
Janssen seeks to expand use of Erleada (apalutamide) in the treatment of patients with metastatic hormone-sensitive prostate cancer
4 June 2019 - Application supported by data from the Phase 3 TITAN study which were recently presented at the ...
Posted by Michael Wonder on 31 May 2019
Pfenex and Alvogen announce European Medicines Agency accepts marketing authorisation application for PF708
30 May 2019 - Pfenex and Alvogen today announced that the EMA has accepted the marketing authorisation application submitted by our ...
Posted by Michael Wonder on 29 May 2019
European Medicines Agency accepts marketing authorisation application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review
28 May 2019 - Prestige BioPharma announced that EMA has validated and accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 28 May 2019
Santhera submits marketing authorisation application to the European Medicines Agency for Puldysa (idebenone) in Duchenne muscular dystrophy
27 May 2019 - Santhera Pharmaceuticals announces that it has submitted a marketing authorisation application for Puldysa (idebenone) for the ...
Posted by Michael Wonder on 25 May 2019
Sosei Heptares notes that a valid marketing authorisation application for QVM149, a potential new inhaled combination therapy for asthma, has been filed with the European Medicines Agency
24 May 2019 - Sosei Group Corporation announces it has been notified today by its strategic alliance partner Novartis that ...
Posted by Michael Wonder on 09 May 2019
Nabriva Therapeutics announces submission of marketing authorisation application for lefamulin to treat community-acquired pneumonia in adults by European Medicines Agency
8 May 2019 - Nabriva Therapeutics announced that the Company’s marketing authorisation application for both the intravenous and oral ...
Posted by Michael Wonder on 28 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept marketing authorisation application to the EMA for MDS and beta-thalassemia
26 April 2019 - Submission to EMA follows biologics licensing application submission to U.S. FDA earlier this month. ...
Posted by Michael Wonder on 27 Apr 2019
Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of type 2 diabetes
26 April 2019 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for oral ...
Posted by Michael Wonder on 04 Apr 2019
EMA validates Daiichi Sankyo’s marketing authorisation application for pexidartinib for treatment of patients with TGCT, a rare, debilitating, non-malignant tumour
4 April 2019 - EU marketing authorisation application follows recent filing of the pexidartinib new drug application by the U.S. FDA ...
Posted by Michael Wonder on 02 Apr 2019
European Medicines Agency accepts Takeda’s marketing authorisation application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease
1 April 2019 - Additional treatment modality would provide greater choice in how patients receive gut-selective biologic vedolizumab. ...
Posted by Michael Wonder on 02 Apr 2019
Heron announces European Medicines Agency validation of marketing authorisation application for HTX-011 for post-operative pain management
1 April 2019 - Heron Therapeutics today announced that the marketing authorisation application for its investigational agent, HTX-011, for post-operative pain, ...