First Stool-Based Colon Cancer Screening Test Receives FDA Approval with Proposed Medicare Coverage
August 11th 2014The FDA today approved the first non-invasive colorectal screening test to indicate the presence of certain abnormal growths that may be colorectal cancer or precursors to colon cancer.
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FDA Expands Access to Lumizyme, Drops Risk Mitigation Requirements
August 5th 2014With its expanded approval of Lumizyme (alglucosidase alfa) to treat all Pompe disease patients, regardless of age or time of disease onset, the FDA has eliminated the Risk Evaluation and Mitigation Strategy program that restricted the drug's use to those aged 8 years or older with late-onset disease.
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