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Transcranial Magnetic Stimulation Cleared for Anxiety

[ Price : $8.95]

FDA clears a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial m...

CGMP Deviations at Bioiberica

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FDA warns Spains Bioiberica about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

False/Misleading Claims for Imprimis Rx Compounded Drugs: FDA

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FDA warns Imprimis Rx that professional promotional materials for a compounded ophthalmic drug make false and misleading statement...

Clinical Hold Lifted on Viking X-ALD Trial

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FDA lifts a clinical hold against Viking Therapeutics VK0214 in patients with X-linked adrenoleukodystrophy.

Merck Hits Brakes on Lynparza in Colorectal Cancer

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Merck halts a Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unre...

CDERs Cavazzoni Adds Deputy for Substance Abuse

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CDER director Patrizia Cavazzoni selects associate director for controlled substances Marta Sokolowska to serve as deputy Center d...

Caution Advised for Continuing Education Funding: WLF

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The Washington Legal Foundation says an OIG advisory opinion puts life sciences companies on notice to be cautious in the way they...

Pain Doctor Settles Company Kickback Allegations

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California pain doctor Gerald Sacks agrees to pay $271,259.12 to resolve anti-kickback allegations involving drugs manufactured by...

Roche Elecsys Amyloid Plasma Panel is Breakthrough Device

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FDA grants breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimers disease...

Apellis NDA for Geographic Atrophy Drug

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FDA accepts for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 the...