FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Orexigen Encouraged by FDA Dispute Resolution for Obesity NDA

[ Price : $8.95]

An FDA response to an earlier Orexigen dispute resolution request indicates that CDER supports further discussions on a potentiall...

FDA Approves Expanded Use for ExAblate Pain Ultrasound

[ Price : $8.95]

FDA approves InSightecs ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients.

Judge Orders FDA to Approve Watsons Generic Actos

[ Price : $8.95]

A Washington, DC federal judge sides with Watson Laboratories and sets a judicial precedent by ordering FDA to approve Watson Labo...

Info on Rx Drug User Fee Form Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a collection of information on the prescription drug user fee cover sheet to the Office of Ma...

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...

Actelion NDA for Pulmonary Hypertension Drug Submitted to FDA

[ Price : $8.95]

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

FDA Approves Supernus NDA for Epilepsy

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ 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...