Trevena's IV Opioid Not Quite 'Ready for Primetime,' US FDA Panel Concludes
Advisory committee votes 8-7 against approval of the novel opioid; several members say they would change their vote with more data.
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Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.