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King Challenges ZymoGenetics BLA Data

[ Price : $8.95]

A King Pharmaceuticals citizen petition says FDA should not allow ZymoGenetics to follow an abbreviated pathway to BLA approval fo...

FDA Says Consumers Buying 'Risky' Imported Drugs

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An FDA study finds consumers are still buying imported drugs and the agency warns of the inherent dangers.

CMC Data in Surfaxin Response

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Discovery Laboratories files a formal response to FDAs 4/07 approvable letter for Surfaxin.

Marshals Seize General Therapeutics Drugs, Supplements.

[ Price : $8.95]

FDA says U.S. marshals seized more than $300,000 in General Therapeutics drugs, dietary supplements, and raw ingredients.

Aida Turturro Urges Glucose Control with Lantus Pen

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Actress Aida Turturro appears in a Sanofi-Aventis online video touting her positive experience controlling blood sugar with the La...

FDA Mulls Foreign-based Inspection Offices

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FDA commissioner Andrew von Eschenbach tells Congress the agency plans to establish field offices in foreign countries, such as In...

Pozen Responds to Approvable Letter on Migraine Drug

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Pozen says it has submitted a full response to a recent approvable letter on migraine drug Trexima.

Chinese Manufacturer Warned on API Problems

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FDA warns Chinas Northeast General Pharmaceutical Factory on cGMP deviations at its Shenyang API manufacturing facility

Premarin-Cancer Case Dismissed

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A Minnesota judge dismisses a suit claiming Wyeths Premarin and Prempro caused breast cancer for lack of scientifically valid evid...

FDA Clears Bone Marrow Harvester

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FDA clears a StemCor Systems 510(k) for the MarrowMiner, intended for use in harvesting bone marrow.