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clat Wants Unapproved Drugs Off Market

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clat asks FDA to apply regulations on unapproved new drugs to five companies marketing unapproved neostigmine methylsulfate produc...

Dakota Labs Consent Decree Approved

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FDA says a federal judge has accepted a consent decree closing Dakota Laboratories until CGMP violations are corrected.

Amgen Drug Fails Dyspnea Trial

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Amgen and Cytokinetics say their omecamtiv mecarbil failed to meet its endpoint in a trial with acute heart failure patients.

LipoScience Says New Cholesterol Marker Shows Promise

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Researchers say that measuring HDL-P may be a better marker for cardiovascular risk in patients receiving statin therapy.

FDA Clears Abyrxs Hemasorb Plus

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FDA clears an Abyrx 510(k) for its new resorbable hemostatic bone putty, Hemasorb Plus.

FDA Taps Plaisier as New Top Cop

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FDA selects former Central Region food and drug director Melinda Plaisier as the agencys new associate commissioner for regulatory...

MiMedx Challenges FDA Untitled Letter

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MiMedx says it disagrees with FDAs position that its amnion/chorion injectables are not eligible to be marketed under Section 361 ...

FDA Approves New Warner Chilcott Contraceptive

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FDA approves a Warner Chilcotts Lo Minastrin FE (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol t...

FDA Develops Hemagglutinin Antigen Measurement

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FDA scientists describe a newly-developed technique for measuring the amount of hemagglutinin antigen in flu vaccines.

Latest FDA Warning Letters

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In its latest batch Henry A. Frazer, Jabones Pardo, John Brasil Dairy, Stewart Pharmaceuticals, and Sundial Herbal Products.