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Panel to Discuss NDA for Chronic Fatigue Drug

[ Price : $8.95]

Federal Register Notice: FDAs Arthritis Advisory Committee will meet 12/20 to discuss a Hemispherx Biopharma NDA for Ampligen to t...

Communication Breakdown? CDER Liaison Staff Will Help

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A CDER official discusses a new PDUFA 5 program that establishes liaison staff for drug sponsors who have requested information fr...

Actelion NDA for Pulmonary Hypertension Drug Submitted to FDA

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Actelion Pharmaceuticals submits NDA for Opsumit (macitentan), indicated for treating patients with pulmonary arterial hypertensio...

FDA Approves Supernus NDA for Epilepsy

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FDA approves a Supernus Pharmaceuticals NDA for Oxtellar XR (oxcarbazepine), indicated as adjunctive therapy in treating partial e...

FDA Reports Oculogyric Crisis Seen in Zyrtec Patients

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FDA says it has identified a potential safety issue oculogyric crisis with McNeil Consumers Zyrtec (cetirizine HCl) and updates t...

FDA OKs Eisai Anti-Seizure Drug

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FDA approves Eisai, Inc.s Fycompa tablets to treat partial onset seizures in patients with epilepsy.

CEL-SCI Gains Safety Backing from Data Monitoring Panel

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CEL-SCI Corp. says a safety data interim review of a pivotal Phase 3 study of Multikine (leukocyte interleukin, injection) by an I...

VuComp PMA Approved for Mammography CAD System

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FDA approves a VuComp for its M-Vu CAD system (version 2) for digital mammography.

Drug Industry Comments on Suicidality in Clinical Trials

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Drug company comments offer revisions and clarification points on FDAs draft guidance on Suicidal Ideation and Behavior: Prospecti...

CDER Moving Forward with REMS Standardization, Guidance

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CDER associate director for drug safety operations Theresa Toigo discusses the Centers efforts to standardize REMS programs and de...