Bristol Erbitux: Colorectal Refiling Within 9 Months; Broader Package In 2004
Bristol-Myers Squibb could refile Erbitux in irinotecan-refractory colorectal cancer by July, Exec VP Donald Hayden told the Bear Stearns healthcare conference in New York City Sept. 17
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.
