A number of companies were due or potentially due to appear before the European Medicines Agency’s drug evaluation committee, the CHMP, this week to answer questions in person about their marketing applications.
Sponsors of seven medicines were due or potentially due to appear before the European Medicines Agency this week to provide an oral explanation about marketing authorization applications (MAAs) for which they are seeking pan-EU approval.
Three of these oral explanation meetings concern MAAs for new drugs that are in the later stages of the regulatory...
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.
