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Exact Sciences PMA Module for Colorectal Cancer Screener

[ Price : $8.95]

Exact Sciences Corp. files the first PMA module for its stool DNA colorectal cancer screening test.

Panel to Discuss Janssens NDA for Type 2 Diabetes

[ Price : $8.95]

Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/10/13 to discuss Janssens NDA for ...

Cellular, Tissue and Gene Therapies Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 1/15/13 to discuss intramural resea...

Boehringer Ingelheim Reports Phase 2 Volasertib Data in Adults with AML

[ Price : $8.95]

Boehringer Ingelheim Pharmaceuticals reports positive preliminary results of a Phase 2 study of volasertib in newly diagnosed pati...

Celldex Phase 2b Study Backs Benefit in Breast Cancer

[ Price : $8.95]

Celldex Therapeutics says final results from its Phase 2b EMERGE study of CDX-011 supports overall survival benefit in advanced br...

OIG Urges Action on Investigator Disclosures, Device Safety Events

[ Price : $8.95]

An OIG report continues to recommend that FDA require sponsors to submit financial information as part of the pretrial application...

High Court to Review Pay-for-Delay Generic Case

[ Price : $8.95]

The U.S. Supreme Court agrees to review recent federal appeals court ruling concerning a Federal Trade Commission case against a p...

FDA Panel Nixes Zogenix Pain Drug Due to Abuse Potential

[ Price : $8.95]

An FDA advisory committee votes 2 to 11 against recommending approval for Zogenix pure hydrocodone pain medication Zohydro ER due ...

Genentech Says Perjeta Extends Survival in Breast Cancer

[ Price : $8.95]

Genentech reports that a Phase 3 study shows that Perjeta, Herceptin, and docetaxel extended survival in HER2-positive breast canc...

LifeVantage Recalls Dietary Supplement

[ Price : $8.95]

LifeVantage recalls its dietary supplement Protandim due to the possibility of small metal fragments in the final product.