Entereg User Fee Date Pushed Back To May
This article was originally published in The Pink Sheet Daily
Executive Summary
Extension allows FDA to review revised RiskMAP recently submitted by Adolor for the postoperative ileus treatment.
You may also be interested in...
FDA Needs More Time To Review GSK/Adolor’s Entereg
Adolor tells investors that FDA will not act on the postoperative ileus treatment in time to meet the May 10 PDUFA date.
FDA Needs More Time To Review GSK/Adolor’s Entereg
Adolor tells investors that FDA will not act on the postoperative ileus treatment in time to meet the May 10 PDUFA date.
Wyeth/Progenics’ Relistor: FDA Says Yes, EU Likes It, Too
Compound helps bowel function in dying patients on opioids.