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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...

FDA Clears Lensar Laser for Corneal Incisions

[ Price : $8.95]

FDA clears a Lensar 510(k) for its laser system for use in executing corneal incisions during cataract surgery.

CDER First-Cycle Approvals Highest in 20 Years: Jenkins

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CDER Office of New Drugs director John Jenkins says the first-cycle approval rate in 2012 is at the highest level in 20 years.

Exact Sciences PMA Module for Colorectal Cancer Screener

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

OIG Urges Action on Investigator Disclosures, Device Safety Events

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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

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

Qualitest Recalls Hydrocodone/Acetaminophen Tablets

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Qualitest recalls 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10mg/500mg.

LifeVantage Recalls Dietary Supplement

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

Bayer Recalls BronkAid Due to Missing Labeling

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Bayer HealthCare recalls its BronkAid Caplets Dual Action Formula product after discovering that certain Drug Facts information wa...