Tag: marketing authorization application
June 29, 2018
European CHMP Adopts Positive Opinion for Yescarta (axicabtagene ciloleucel)
Kite, a Gilead Company (Nasdaq:GILD), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)... June 28, 2018
Alexion Submits Application for Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria in the EU
Alexion Pharmaceuticals (NASDAQ:ALXN) announced the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for ALXN1210, the... April 30, 2018
Sanofi: FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted priority review the Biologics License Application (BLA) for cemiplimab for the...
April 6, 2018
Is this the Next Botox? Evolus’s Phase 3 Study Met Primary Endpoints
Botox has long been one the best solutions for smoothing wrinkle lines, managing skin breakouts, lifting lips and more, but... March 26, 2018
Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults With Type 1 Diabetes
Lexicon Pharmaceuticals (Nasdaq:LXRX) announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug... February 27, 2018
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Recent Operational Progress
Atara Biotherapeutics (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases,... January 2, 2018