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Researchers See Way to Prevent Diabetes

[ Price : $8.95]

Columbia University Medical Center researchers say that targeting the MK2 enzyme, which raises both sugar and insulin levels in th...

Cohera Files Final PMA Module for Surgical Adhesive

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Cohera Medical files its fourth and final PMA module for its TissuGlu Surgical Adhesive.

FDA Ends Veterinary Advisory Committeee

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Federal Register Final rule: FDA terminates the Veterinary Medicine Advisory Committee.

FDA Approves New Janssen Hepatitis C Drug

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FDA approves Janssens Olysio ((simeprevir), the third new drug in two years to treat chronic hepatitis C virus infection, a diseas...

FDA Clears Dallen Medical 510(k) for Tensyn Band

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FDA clears a Dallen Medical 510(k) for its Tensyn band for fixation of ankle syndesmosis.

FDA Rejects Forest/Gedeon Antipsychotic

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FDA issues a complete response letter to Forest Laboratories and Gedeon Richter for an NDA for cariprazine, an atypical antipsycho...

FDA Still Concerned About Dietary Supplement GMPs

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FDA Division of Dietary Supplement Programs director Daniel Fabricant says too many dietary supplement manufacturers still have ma...

Banzel Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Banzel tablets 100 mg were not withdrawn from sale for reasons of safety or effective...

Let Manufacturers Communicate More Safety Info: Industry

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The drug industry-based Medical Information Working Group says drug manufacturers should have more freedom to communicate subgroup...

Shuren: Bill on Software Regulation is Premature

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CDRH director Jeffrey Shuren tells a House hearing that it is premature to pass legislation to outline a framework for FDA to foll...