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image: Picking Up the Pace

Picking Up the Pace

By | January 1, 2016

FDA designations promise to expedite the approval of drugs for conditions ranging from infectious disease to cancer.

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image: Diagnostics Group Refutes FDA’s Concerns

Diagnostics Group Refutes FDA’s Concerns

By | December 17, 2015

The Association for Molecular Pathology finds fault in the agency’s report on safety issues associated with certain lab tests.

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image: Drug Produced in GM Chicken Approved

Drug Produced in GM Chicken Approved

By | December 10, 2015

The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.

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image: Fatal-Disease Drug in Limbo

Fatal-Disease Drug in Limbo

By | November 25, 2015

A panel of experts advised the US Food and Drug Administration that BioMarin Pharmaceutical has not demonstrated efficacy of its new drug for Duchenne muscular dystrophy.

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image: FDA OKs GM Salmon

FDA OKs GM Salmon

By | November 19, 2015

AquaBounty Technologies’s fast-growing fish is the first genetically modified animal approved by the US Food and Drug Administration.

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image: FDA: Lab Tests Can Cause Harm

FDA: Lab Tests Can Cause Harm

By | November 17, 2015

The US Food and Drug Administration cites cases in which laboratory-developed tests “may have caused or have caused actual harm to patients.”

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image: Clinical Trial Data Underreported: Study

Clinical Trial Data Underreported: Study

By | November 16, 2015

One-third of the human experiments for approved drugs failed transparency requirements.

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image: Battling the Bulge

Battling the Bulge

By | November 1, 2015

Weight-loss drugs that target newly characterized obesity-related receptors and pathways could finally offer truly effective fat control.

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image: Following FDA OK, 23andMe to Expand Health Prediction

Following FDA OK, 23andMe to Expand Health Prediction

By | October 21, 2015

The personal genomics firm is ramping up its suite of disease-related genetic tests.

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image: FDA Warns Liquid Biopsy Maker

FDA Warns Liquid Biopsy Maker

By | September 25, 2015

The agency fires off a letter to Pathway Genomics, telling the company that its new cancer detection test could harm the public and is not validated by science.

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