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FDA Approves Omnitrope Pen 10

[ Price : $8.95]

FDA approves Sandoz Omnitrope Pen 10 with liquid cartridge.

United Therapeutics NDA for Inhaled Treprosinil

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FDA accepts for review a United Therapeutics NDA for inhaled treprostinil, indicated for treating pulmonary arterial hypertension.

FDA Clears Pioneers Bone Graft

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FDA clears a Pioneer Surgical Technology 510(k) for the FortrOss, a bone graft substitute intended for use in orthopedic applicati...

Erbitux sBLA Submitted

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ImClone submits an sBLA to FDA to expand Erbituxs indication to include first-line treatment of patients with recurrent and/or met...

Novartis Scraps Antibiotic Add on Therapy

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Novartis says it will abandon the development of Aurograb, an add-on therapy for use with antibiotics intended for treating deep-s...

ICH Releases Non-clinical Study Draft

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ICH publishes a draft guidance on drug non-clinical safety studies.

Study Refutes Singulair Possible Suicide Link

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An American Lung Association (ALA)-sponsored study of Mercks asthma therapy Singulair finds no evidence of depression or suicide l...

Vytorin Association with Cancer Risk Uncertain

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A New England Journal of Medicine editorial urges caution in interpreting research results suggesting any association between Vyto...

DTC Ad Value Questioned

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Researchers find DTC ads increase prescription volume for only some of the advertising drugs, leading to questions about ads usefu...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ORyan Industries and Prismic Light International.