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Susan Haigney is lead editor of BioPharm International®.
February 03, 2024
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
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 29, 2024
The company issued the recall because of a package mislabeling problem.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.