(Reuters) - Gardasil, which protects against several strains of Human Papillomavirus, is approved as a vaccine to prevent cervical cancer caused by the virus for use in girls and women ages 9 to 26. The company is seeking a similar expanded label with European regulators.
Merck said the U.S. Food and Drug Administration had agreed to a standard review period for the expanded indication, which usually takes about 10 months. A priority review would have cut the decision time to six months.
Read more at Reuters.com Government Filings News
Merck said the U.S. Food and Drug Administration had agreed to a standard review period for the expanded indication, which usually takes about 10 months. A priority review would have cut the decision time to six months.
Read more at Reuters.com Government Filings News
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