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FDA Clears NEC Medical Diagnostic Display

[ Price : $8.95]

FDA clears an NEC Display Solutions of America 510(k) for its 21.3-inch MultiSync MD211G3 medical diagnostic display.

Lilly Reports Positive Phase 3 Data on Gastric Cancer Drug

[ Price : $8.95]

Eli Lilly says that its REGARD Phase 3 trial involving IMC-1121B (ramucirumab) in patients with metastatic gastric cancer met its ...

Aegerion Reduces LDL-C, But with Safety Risks: Reviewers

[ Price : $8.95]

FDA reviewers say that Aegerion Pharmaceuticals lomitapide mesylate capsules reduced low-density lipoprotein cholesterol by 40%, b...

No FDA Violation Letters on FDAMA Sec 114 Economic Claims

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A Tufts analysis finds that in the past nine years, FDA has not issued a single Warning or untitled letter under Sec. 114 authorit...

Meningitis Possibly Linked to Another NECC Product: FDA

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FDA says its ongoing investigation of New England Compounding Center has raised the possibility of a a patient with possible menin...

Merck Sees Favorable Results with Osteoporosis Drug

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Merck reports that results from a Phase 2 trial for odanacatib showed significantly increased bone mineral density (BMD) over a tw...

Compounding Crisis Shows FDAs Accelerating Weakness

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FDA Webview editor Jim Dickinson says the accelerating meningitis outbreak from New England Compounding Center reveals FDAs own ac...

FDA Accepts Delcath NDA for Chemosaturation System

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FDA accepts for review a Delcath Systems NDA for its proprietary chemosaturation system with melphalan hydrochloride for injection...

FDA Accepts Depomed NDA for Hot Flashes Drug

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FDA accepts for review a Depomed NDA for Serada (extended-release gabapentin tablets), indicated for treating menopausal hot flash...

Reviewers Positive on NPS Pharma Short Bowel Syndrome NDA

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FDA reviewers find favorable efficacy data in an NPS Pharmaceuticals NDA for Gattex injection that seeks an indication for treatin...