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Federal Register Notice: FDAs Arthritis Advisory Committee will meet 12/20 to discuss a Hemispherx Biopharma NDA for Ampligen to t...[ Price : $8.95]
CDER says that 14% of outstanding postmarketing requirements and postmarketing commitments are considered delayed, compared with 1...[ Price : $8.95]
Actelion Pharmaceuticals submits NDA for Opsumit (macitentan), indicated for treating patients with pulmonary arterial hypertensio...[ Price : $8.95]
FDA approves a Supernus Pharmaceuticals NDA for Oxtellar XR (oxcarbazepine), indicated as adjunctive therapy in treating partial e...[ Price : $8.95]
FDA says it has identified a potential safety issue oculogyric crisis with McNeil Consumers Zyrtec (cetirizine HCl) and updates t...[ Price : $8.95]
FDA approves Eisai, Inc.s Fycompa tablets to treat partial onset seizures in patients with epilepsy.[ Price : $8.95]
CEL-SCI Corp. says a safety data interim review of a pivotal Phase 3 study of Multikine (leukocyte interleukin, injection) by an I...[ Price : $8.95]
A CDER official discusses a new PDUFA 5 program that establishes liaison staff for drug sponsors who have requested information fr...