Cervical cancer vaccine approval delayed by FDA

December 18, 2007

The Food and Drug Administration dealt a blow to GlaxoSmithKline PLC in delaying approval of one of the company's most important new products: the cervical-cancer vaccine Cervarix.

GlaxoSmithKline said the FDA sent it a so-called complete response letter, which the regulator issues when the review of a drug or vaccine is completed and questions remain to be answered before approval. More >>

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