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December 02, 2023
Biologics have specific quality considerations that make fast tracking these drugs more difficult.
November 30, 2023
Exagamglogene autotemcel seen as synechdoche.
November 14, 2023
Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.
November 09, 2023
Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.
The document includes recommendations for the reporting and implementation of changes to container closure system components.
November 03, 2023
This is the second biologic approved to treat HS, a painful and reoccurring skin disease.
November 01, 2023
The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.
October 30, 2023
PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.
October 25, 2023
The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.
October 24, 2023
The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.