Makena Pricing Prompts Multi-Pronged Appeals: FDA, FTC – Bayh-Dole?
The uproar among insurers, physicians and patient groups over the relatively high price of KV Pharmaceutical’s new injectable treatment for preventing preterm births, Makena, has elicited appeals to FDA and the Federal Trade Commission for intervention.
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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