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February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
January 31, 2024
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
January 18, 2024
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
January 17, 2024
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
January 15, 2024
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
December 27, 2023
The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.