By Kate Rawson
Perhaps you have heard: The Food & Drug Administration recently determined the future of a controversial drug for a metabolic...
Avandia and Meridia are different drugs with parallel regulatory histories: both are long-marketed treatments for metabolic disease. Both have an increased risk of cardiovascular events. And both were considered for withdrawal at roughly the same time by the same FDA division. But while there were many similarities between the two, the reviews were markedly different with markedly different outcomes.
By Kate Rawson
Perhaps you have heard: The Food & Drug Administration recently determined the future of a controversial drug for a metabolic...
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
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.
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.