FDA

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Blow for Genzyme as FDA finds fault with Allston facility

March 13, 2009
Research and Development, Sales and Marketing FDA, Genzyme

The chances of approval for Genzyme's new Pompe disease drug Lumizyme have diminished dramatically after the US Food and Drug …

FDA finalises transgenic animals guide

January 23, 2009
Research and Development, Sales and Marketing FDA, US, reg

The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA. …

FDA moves to make imports safer

January 16, 2009
Manufacturing and Production FDA, supply chain

The Food and Drug Administration is stepping up efforts to prevent counterfeit and contaminated  medicines entering the US, and is …

Novartis’ Zelnorm pulled from market after safety concerns

April 2, 2007
Sales and Marketing FDA, reg

Zelnorm, the treatment for irritable bowel syndrome, has been withdrawn from the US market after the FDA raised concerns about …

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