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FDA OKs New Labeling for Acetadote

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FDA approves updated labeling for Cumberland Pharmaceuticals Acetadote injection, an intravenous treatment for acetaminophen overd...

FDA OKs Elanco Animal Health sNADA for Swine

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Federal Register Final rule: FDA approves two Elanco Animal Health supplemental NADAs for using tylosin tartrate and tylosin phosp...

Neuralstem Files IND for ALS Treatment

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Neuralstem files an IND for a clinical trial to use its neural stem cell technology in Lou Gehrigs disease.

FDA Clears Ion Beam Applications

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FDA clears an Ion Beam Applications 510(k) for the Pencil Beam Scanning treatment modality for proton therapy.

Appeals Court Reverses Drug Supply Order

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A federal appeals court says PTC Therapeutics does not have to provide an experimental drug to a 16-year-old muscular dystrophy pa...

Abbott Begins New Trial for Xience Stent

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Abbott says it has begun a study called SPIRIT Small Vessel, a clinical trial evaluating a 2.25 mm size of the Xience V Everolimus...

FDA Clears Peak Surgery System

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FDA clears a Peak Surgical 510(k) for the Peak Surgery System.

Leavitt Discusses Partner in Speed Concept

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HHS secretary Mike Leavitt discusses next level of import safety plan third-party certification under FDAs Beyond our Borders in...

FDA, Defense, and Veterans Sign MOU

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Federal Register Notice: FDA provides a notice of a memorandum of understanding between the Office of the Assistant Secretary of D...

FDA Wants More Risk Assessment in New Diabetes Drugs

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FDA says drug companies should immediately implement a new guidance calling for assessment of cardiovascular risk in all drugs bei...