Viela Adds Momentum To Burgeoning NMOSD Market With Pivotal Inebilizumab Results
2019 could be the year when three drugs are approved for rare disease neuromyelitis optica, a previously untreatable condition. Viela Bio is the latest to announce positive data from pivotal trials of its monoclonal antibody inebilizumab.
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The market opportunity in the EU for Alexion’s Soliris has increased following European Commission approval of the additional indication, NMOSD. The EU indications for Bristol-Myers Squibb’s Empliciti have been extended to include use with pomalidomide and dexamethasone in a triplet combination for relapsed and refractory multiple myeloma.
Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.