Tag: European Medicines Agency
October 10, 2019
Krystal Biotech Receives EMA Opinion on KB105
The company's KB105 treatment was previously approved by the US Food and Drug Administration in August 2018.
September 30, 2019
NewLink Genetics and Lumos Pharma to Form Biopharma Company
The agreement is expected to close in Q1 2020. NewLink Genetics will change its name to Lumos Pharma and its...
September 3, 2019
Aridis Tumbles After Phase 2 Trial Fails to Meet Endpoint
Aridis Pharmaceuticals dipped more than 6 percent on the news that AR-105 did not meet its primary endpoint in a... July 23, 2019
Cytokinetics Granted European Orphan Designation for Reldesemtiv to Treat Spinal Musclar Atrophy
Cytokinetics (NASDAQ:CYTK) has announced that the European Medicines Agency (EMA) has granted the company orphan medicinal product designation to reldesemtiv... January 16, 2019
Aeterna Zentaris Receives European Marketing Clearance for Macimorelin
Aeterna Zentaris (NASDAQ:AEZS;TSX:AEZS) announced that the European Medicines Agency (EMA) has granted marketing authorization for macimorelin, an orally available ghrelin agonist,... January 15, 2019
European Medicines Agency validates Oasmia Pharmaceutical AB’s application to add efficacy data to the approved Apealea
Oasmia Pharmaceutical AB (NASDAQ:OASM) AB today announce that the European Medicines Agency (EMA) has validated a type II variation application... December 4, 2018