Archive for the ‘FDA Press Releases’ Category


FDA Press Releases: FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC). Food and Drug Administration–Press [...]

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FDA Press Releases: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA seeks preliminary injunction against New York fish manufacturer

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to [...]

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FDA Press Releases: FDA approves Nymalize–first nimodipine oral solution for use in certain brain hemorrhage patients

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA approves Simponi to treat ulcerative colitis

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Food and Drug Administration–Press Releases

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