Tag: European Medicines Agency

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...
October 19, 2018

Shire: CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks

Shire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, announced today that the European Medicines Agency’s (EMA)...
September 14, 2018

European Medicines Agency Validates Marketing Authorization Application for Trogarzo

Theratechnologies (TSX:TH) is pleased to announce that the European Medicines Agency has confirmed the validity of the marketing authorization application...