Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
ODAC Applauds Effort, But Votes Against Y-mAbs’ I-Omburtamab In Neuroblastoma
US FDA advisory committee voted unanimously that there was not enough evidence to show the monoclonal antibody improves overall survival, but panelists are hopeful that real-world evidence could eventually get the orphan candidate over the finish line.
A Mixed AdComm: REMS Seems Possible For GSK’s Anemia Drug, Dual Indication Likely Needs More Data
Daprodustat gets a thumbs up from a US FDA advisory committee on one of two proposed indications, but panelists indicate preference for strong pharmacovigilance program for GSK’s oral anemia treatment for chronic kidney disease patients.
Y-mAbs’ External Control Problems May Sink Neuroblastoma Candidate I-Omburtamab
In advisory committee briefing documents, the US FDA said control data was not comparable to the single-arm trial and the benefits of the monoclonal antibody were unclear.