Tag: marketing authorization\
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 19, 2018
Krystal Biotech’s KB103 Receives Orphan Medicinal Product Designation in Europe for Dystrophic Epidermolysis Bullosa
Krystal Biotech (NASDAQ:KRYS), a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from dermatological diseases,... April 12, 2018
Emergent BioSolutions Announces Successful Completion of Mutual Recognition Procedure for Market Authorization of BioThrax in European Countries
Emergent BioSolutions (NYSE:EBS) announced the successful completion of the Mutual Recognition Procedure (MRP) for market authorization of BioThrax® (Anthrax Vaccine Adsorbed)...
April 11, 2018
Helius Medical Begins Listing on the NASDAQ
A company getting approval to list to the NASDAQ means a more international reach for Canadian companies listing on 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... March 19, 2018