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Merck Plans Rolling Boceprevir NDA

[ Price : $8.95]

Merck says it will complete a rolling NDA this year for boceprevir, an investigational oral hepatitis C protease inhibitor.

FDA Warning on Miracle Mineral Solution

[ Price : $8.95]

FDA warns consumers not to drink a product sold on the Internet as a medical treatment because it becomes a bleaching chemical whe...

Four New Medication Guides Announced

[ Price : $8.95]

FDA releases four new and three updated Medication Guides.

Wright Settles Marketing Probe

[ Price : $8.95]

Wright Medical Technology agrees to pay nearly $8 million to resolve a federal investigation into its relationships with orthopedi...

FDA Clears Zone Life Body-contouring Device

[ Price : $8.95]

FDA clears a Zone Life 510(k) for the i-Lipo Ultra body-contouring device.

FDA Provides Phase 3 Guidance for AcelRx Cancer Drug

[ Price : $8.95]

FDA provides Phase 3 guidance to AcelRx for its ARX-02 breakthrough cancer pain drug at an end-of-Phase 2 meeting.

FDA Clears Collagen Matrix Dental Membrane

[ Price : $8.95]

FDA clears a Collagen Matrix 510(k) for its Collagen Dental Membrane derived from porcine dermis and intended for use in oral surg...

FDA San Juan Director Under Investigation, Sharfstein Says

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FDA principal deputy commissioner Josh Sharfstein tells a Congressional hearing that San Juan District director Maridalia Torres i...

Alliance for Stronger FDA Pushes for More Funding

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The Alliance for a Stronger FDA says it will continue to push for higher agency funding, especially given the potential for a hiri...

FDA Orders Unapproved Oral Colchicine Off the Market

[ Price : $8.95]

FDA orders drug manufacturers of unapproved single-ingredient oral colchicine, a medication used for treating gout and familial Me...