AstraZeneca's Vandetanib Approval Includes REMS With Distribution Restrictions
The medullary thyroid cancer drug's Risk Evaluation and Mitigation Strategy requires mandatory enrollment and certification of prescribers and pharmacists, which should help ensure the drug is used primarily in patients with symptomatic, progressive disease.
Learn what's happening at the US FDA. On the go.
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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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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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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.
