CEO Polymeropoulos tells the Pink Sheet that both subject and severity of letter regarding description of products on corporate website seem like an overreaction by the agency.
The US FDA's warning letter to Vanda Pharmaceuticals Inc. seems relatively straightforward – the agency says the company included indications but not safety information when it listed its marketed products on its website – but the company says the correspondence actually raises a host of questions.
"We understand the words of the letter. What we are puzzled by is the reasoning for this action," Vanda CEO...
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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.’
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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