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FDA 'Complete Response' for Valeant Seizure Drug

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FDA issues Valeant Pharmaceuticals a complete response letter for an NDA for Potiga (ezogabine), an investigational anti-epileptic...

FDA Grants Octapharma Fast Track for Octaplex

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FDA grants Octapharma USA fast track status on its investigational drug Octaplex as a treatment for reversing anticoagulation ther...

FDA Patient Focus Urged to Improve Drug Safe Use

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Workshop participants looking at how health literacy can promote safer drug use say FDA needs to take a more active role in a numb...

FDA Clears Quests Simplexa Flu Test

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FDA clears Quest Diagnostics Simplexa molecular flu test.

CDRH Head Dismisses 'Flawed' Study on Device Delays

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CDRH director Jeffrey Shuren dismisses a recent study on device approval delays, calling it highly flawed with its inadequate samp...

California Stem Cell Files IND for Spinal Muscular Atrophy

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California Stem Cell files an IND with FDA to begin a Phase 1 safety study for a stem cell-derived therapy to treat Spinal Muscula...

FDA Approves New Cubicin Dosing

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FDA approves a shorter dosing time for Cubicin for treating MRSA.

FDA Panel Rejects Prostate Cancer Drugs

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Members of FDAs Oncologic Drugs Advisory Committee vote not to recommend expanding use of GlaxoSmithKlines Avodart (dutasteride) a...

Advisors to Weigh Vandetanib Toxicity

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether a proposed indication for AstraZenecas vandetanib should ...

FDA Clears X-spine Fusion System

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FDA clears an X-spine 510(k) for the AXLE Interspinous Fusion System, intended for use in providing spinal stability for lumbar fu...