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Gilead Science NDA for Cystic Fibrosis Patients

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Gilead Sciences submits an NDA for aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy for treat...

GSK Intimidated Avandia Researcher: Grassley

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Sen. Chuck Grassley says GlaxoSmithKline tried to intimidate a university researcher who raised early questions about Avandia safe...

FDA Addresses Unretrieved Device Fragment Injuries

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FDA says it receives over 1,000 adverse event reports each year related to unretrieved device fragments (UDF) left in patients aft...

FDA Approves Mircera Anemia Treatment

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FDA approves Roches erythropoietin receptor activator Mircera for treating chronic kidney disease anemia.

NZ Zyprexa Ad Complaint Upheld

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New Zealands Advertising Standards Authority says a Lilly booklet depicting Zyprexa success stories violated the countrys drug ad ...

Celebrity Endorsements Out in China Drug Ads

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Chinas State Food and Drug Administration bans celebrities from appearing in drug ads.

Takeda Runs Actos Safety Ads

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Takeda runs ads touting Actos safety in 82 newspapers and news magazines.

Scharmann Responds to Foreign Inspections Comments

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Consulting editor John Scharmann responds to FDA field employees comments on his recent article, FDAs Foreign Model Could be Good ...

FDA Clears Medtronic Biliary Stent

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FDA clears a Medtronic 510(k) for the Complete SE (self-expanding) Biliary Stent System, indicated for use in the palliative treat...