Cervarix, Gardasil Set For FDA Advisory Committee Review
This article was originally published in The Pink Sheet Daily
GlaxoSmithKline knew it was in for scrutiny of its novel AS04 adjuvant, but review of Merck's application to make Gardasil gender-neutral could offer backdoor to re-examine the HPV vaccine's safety record.
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The drug maker hopes the data will reverse a long-delayed approval in the U.S., where Merck's Gardasil has a commanding lead.
Merck says immune response trial provides "no clinically relevant information."