OR WAIT null SECS
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
February 04, 2024
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
January 31, 2024
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 25, 2024
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
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.