FDA Revisits Old Issues For Novartis' COPD Drug Indacaterol At Panel Review
The Pulmonary-Allergy Drugs Advisory Committee is being asked whether safety and efficacy have been established for two doses of the chronic obstructive pulmonary disease treatment Arcapta, the same problem that caused an earlier "complete response" letter.
Learn what's happening at the US FDA. On the go.
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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.
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