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

Cascadian Therapeutics Gets Pediatric Investigation Plan Waiver for Lead Candidate

Cascadian Therapeutics received a pediatric waiver from the European Medicines Agency (EMA) for their lead candidate tucatinib, currently in a...