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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 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.
The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.
The industry’s M&A activity is on the up and expected to continue to rise in 2024.
February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
January 31, 2024
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 29, 2024
The company issued the recall because of a package mislabeling problem.