VEGFbTM Has Been Granted Orphan Drug Designation By The FDA For The Treatment Of Advanced Melanoma (Medical News Today)
PhiloGene, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VEGFb for the treatment of patients with advanced melanoma. This approval is for a larger subset of melanoma patients than was requested, and includes melanoma in stages IIb through IV.

Successful Inspection Of Helsinn Birex Pharmaceuticals By The U.S. FDA (PharmaceuticalOnline)
Helsinn is pleased to announce that Helsinn Birex Pharmaceuticals, its drug facility in Dublin, Ireland, has undergone a successful inspection by the US Food and Drug Administration (FDA) without any Form 483 observations.