FDA: BioDelivery Sciences Should Improve “Safe Use” REMS Provisions For Oral Fentanyl Approval
Onsolis “complete response” letter is “as close to approval as one can get without having it,” BDSI CEO says.
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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