FDA Clears Victoza, But Warnings And More Studies Pose Hurdles
That FDA's approval of Novo Nordisk's Victoza (liraglutide) uses its full cadre of FDA Amendments Act-granted drug safety controls - a Risk Evaluation and Mitigation Strategy and mandatory post-marketing requirements - is not surprising, given the concern about a potential cancer risk. But it is a disappointment to investors
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.




