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FDA 'Complete Response' for Valeant Seizure Drug

[ Price : $8.95]

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

Inspire Medical to Begin Pivotal Apnea Trial

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FDA gives Inspire Medical Systems approval to begin a pivotal clinical trial called STAR (Stimulation Therapy for Apnea Reduction)...

Review Process Strains FDA-Industry Relations

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PricewaterhouseCoopers says relations between industry and FDA over regulatory review processes are becoming strained.

FDA Grants 'Orphan' Status for Radiation Exposure Drug

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FDA grants Cleveland BioLabs an orphan drug designation for CBLB502, a drug under development for treating radiation exposure.

CDER Affirms Ranbaxy Generic Aricept Exclusivity

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CDER says that Ranbaxy is entitled to 180-day marketing exclusivity for generic Aricept.

Concerns Raised About ABSSSI Draft Guidance

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PhRMA raises concerns with two aspects of an FDA draft guidance on developing drugs to treat acute bacterial skin and skin structu...

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...

Optimer Pharma NDA for New Antibiotic

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Optimer Pharmaceuticals files an NDA for fidaxomicin, indicated for treating patients with clostridium difficile infection.

Onus is on Firms, FDA for Credible Social Media Info: Report

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A New England Journal of Medicine report says FDA and industry each should be responsible for the credibility of drug and device i...