Repligen Receives Orphan Drug Designation From the FDA for RG1068 for MRI Imaging of the Pancreas (RedNova)
WALTHAM, Mass., Nov. 21 /PRNewswire-FirstCall/ -- Repligen Corporation announced today that the Office of Orphan Products Development of the U.S.

FDA Accepts DOR BioPharma's NDA Filing for orBec(R) (Market Wire via Yahoo! Finance)
DOR BioPharma, Inc. announced today that the U.S. Food and Drug Administration ("FDA") has accepted the Company's New Drug Application for orBec for the treatment of gastrointestinal Graft-versus-Host disease. The FDA has granted the orBec NDA application a standard review designation and established a target action date of July 21, 2007 for completion of review of the NDA in accordance with

Fougera gets US FDA nod for generic Sulfacetamide Sodium (PharmaBiz)
Specialty pharmaceutical manufacturer Fougera, a division of Altana Inc, announced has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10 per cent. The generic formulation compares to Klaron by Dermik, whose patent has expired.