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Allergan Gains Approval for Juvederm Lip Augmentation

[ Price : $8.95]

FDA approves an Allergan PMA to market Juvederm Ultra XC, a dermal filler for injection into the lips and perioral area for lip au...

Panel to Discuss Fluroquinolone Antibacterials

[ Price : $8.95]

Federal Register Notice: FDAs Antimicrobial Drugs and the Drug Safety and Risk Management Advisory Committees will discuss 11/5 sy...

Public Citizen Blasts NEJM Ethics

[ Price : $8.95]

Public Citizens Michael Carome says the New England Journal of Medicine breached its own ethics by publishing a commentary that gr...

Panel to Discuss Bulk Drug Substance Nominees

[ Price : $8.95]

Federal Register Notice: FDAs Pharmacy Compounding Advisory Committee will meet 10/27-28 to discuss ten bulk drug substances nomin...

Questionable Results for Priority Review Vouchers: Study

[ Price : $8.95]

Bloomberg News reports that FDA is trying to increase drug company inspections in China to ensure the quality of finished drugs an...

Cardiac Ablation Remote into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the steerable cardiac ablation catheter remote control system into Class 2.

Guidance on Veterinary Feed Directive Q&A

[ Price : $8.95]

Federal Register Notice: FDA releases a small entity compliance guide and guidance entitled Veterinary Feed Directive Regulation Q...

Orphan Status for Blueprint Medicine Liver Cancer Therapy

[ Price : $8.95]

FDA grants Blueprint Medicines an orphan drug designation for BLU-554 for treating hepatocellular carcinoma.

FDA Clears OB-Tools Fetal Heart Monitor

[ Price : $8.95]

FDA clears an OB-Tools 510(k) for its fetal heart rate monitoring unit, which is integrated into its TrueLabor maternal fetal moni...

Jazz NDA for Defibrotide Accepted for Priority Review

[ Price : $8.95]

FDA accepts for priority review a Jazz Pharmaceuticals NDA for defibrotide, indicated for treating patients with hepatic veno-occl...