Entereg news from FierceBiotech
NewsFDA OKs Adolor's Entereg in first approval
Exton, PA-based Adolor hit a major milestone with the FDA's approval of Entereg for postoperative ileus, a common condition following surgery that can extend a patient's hospital stay. This is the Read more...
FDA delays Entereg decision
GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the Read more...
GSK, Adolor face another Entereg delay
The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an Read more...
ALSO NOTED: Adolor shares rise on NDA news; Indevus plans Phase III; Exelixis earns milestone; and much more...
> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Read more...
ALSO NOTED: Vernalis reports "striking" weight loss in trial; Genmab shares surge on Phase III; FDA wants more time on Entereg;
> Vernalis is reporting "striking" weight loss results in its Phase I trial of the obesity drug V24343. Read more...
Investors cheer FDA's acceptance of Entereg response
Shares of Adolor took off this morning, climbing 18 percent after the company issued a joint release with GlaxoSmithKline that the FDA had accepted their response to the agency's Read more...
| Press ReleasesPRESS RELEASE: FDA Accepts for Review Complete Response to Approvable Letter for Entereg for POI FDA Accepts for Review Complete Response to Approvable Letter for Entereg for POI - Adolor and GSK Also Submitted Complete Response to Request the Release of the Clinical Hold for Read more... |
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