FDA Approvals - Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for PROMACTA(R)
Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for PROMACTA(R) NDA (Centre Daily Times)
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced today that the U.S. Food and Drug Administration has extended the priority review period for GlaxoSmithKline's (GSK) New Drug Application (NDA) for PROMACTA(R) (eltrombopag) for the short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP). The Prescription Drug User Fee action date has been extended to September 19, 2008.
Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for PROMACTA(R) NDA (Business Wire via Yahoo! Finance)
SAN DIEGO----Ligand Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration has extended the priority review period for GlaxoSmithKline s New Drug Application for PROMACTA for the short-term treatment of chronic idiopathic thrombocytopenic purpura .
FDA Advisory Committee Unanimously Recommends Approval Of Ustekinumab For Treatment Of Moderate To Severe Plaque ... (Medical News Today)
Centocor, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) has unanimously recommended the approval of ustekinumab, a new subcutaneous, investigational biologic therapy for the treatment of adult patients with moderate to severe plaque psoriasis.