Aventis/Genta Genasense Melanoma NDA Expected To Go Before FDA Oncology Committee In May
This article was originally published in The Pink Sheet Daily
FDA has granted priority review to the NDA for oblimersen sodium for treatment in combination with chemotherapy. The user fee action date is June 8.
You may also be interested in...
FDA’s proposal for relabeling of antihypertensive agents is based on prior recommendations by the committee that information on cardiovascular outcomes related to blood pressure lowering be included as class labeling.
FDA’s Oncologic Drugs Advisory Committee will meet in Atlanta to review Bristol’s multi-targeted kinase inhibitor dasatinib for two leukemia indications.
FDA’s Psychopharmacologic Drugs Advisory Committee rules safety for modafinil product in children with attention deficit/hyperactivity disorder has not been adequately demonstrated.