Arcapta Quality Of Life Data For High Dose Cannot Overcome Efficacy Questions
FDA's Pulmonary-Allergy Drugs Advisory Committee endorses approval of the 75 mcg dose of indacaterol but recommends against approval of Novartis' preferred 150 mcg dose of the chronic obstructive pulmonary disease drug.
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.
