Blog
RSS FeedPosted by Michael Wonder on 02 Jul 2019
Alnylam submits marketing authorisation application to the EMA for givosiran for the treatment of acute hepatic porphyria
1 July 2019 - Patients receiving givosiran in pivotal Phase 3 ENVISION study had a 74% mean reduction in annualised rate ...
Posted by Michael Wonder on 29 Jun 2019
Aimmune submits marketing authorisation application to EMA for AR101 for peanut allergy
28 June 2019 - Aimmune Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for AR101, ...
Posted by Michael Wonder on 26 Jun 2019
Pacira BioSciences announces validation of Exparel marketing authorisation application from European Medicines Agency
25 June 2019 - Advances global expansion strategy to minimise post-surgical opioid use worldwide. ...
Posted 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 ...