Celgene Revlimid PDUFA Date Extended to January
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA pushes back the user fee date for Celgene’s myelodysplasic syndromes therapy Revlimid, originally set for Oct. 7, by three months.
You may also be interested in...
Prasugrel Delay Shifts Focus To Possible August Advisory Committee
FDA extends user fee date for the novel anti-platelet drug to Sept. 26.
Prasugrel Delay Shifts Focus To Possible August Advisory Committee
FDA extends user fee date for the novel anti-platelet drug to Sept. 26.
Revlimid Approved With Safeguards Against Fetal Exposure
Education and prescribing safety program for Celgene’s Revlimid will restrict distribution and address risks of fetal exposure; the firm has ongoing studies to assess teratogenicity.