The European Medicines Agency will encourage companies to submit their orphan designation applications through a new portal when it is launched on June 15. Applications through existing processes will be accepted until Sept. 15.
The European Medicines Agency is set to launch on June 15 a new secure online portal for drug companies to submit their orphan designation applications and to manage post-designation activities.
The new portal is being launched as part of an EMA-wide program to improve the way the agency records and...
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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.’
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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