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

Scholar Rock Announces Positive Opinion by the European Medicines Agency

Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play...