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Pfizer's Arthritis Pill Raises Safety Concerns, FDA Staff Says

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Pfizer Inc. (PFE)'s experimental pill to treat rheumatoid arthritis, one of the company's leading drug candidates, raised "serious safety concerns," U.S. regulators said today.The pill, tofacitinib, carried increased risks of serious infections and malignancies, in particular a higher chance of lymphoma, Food and Drug Administration staff wrote. The agency released the report ahead of a May 9 meeting of FDA medical advisers who will review tofacitinib's benefits and risks.The regulator is scheduled to rule on tofacitinib by August.To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net;To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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fonte: Bloomberg
data di creazione: 07/05/2012
data di modifica: 07/05/2012