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

Dova Pharmaceuticals Signs Exclusive Distribution Agreement with Fosun Pharma For Mainland China and Hong Kong

Dova Pharmaceuticals (NASDAQ:DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is...