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Susan Haigney is lead editor of BioPharm International®.
June 26, 2024
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.
June 24, 2024
A new initiative will advance access to quality medicines and vaccines in Africa.
June 20, 2024
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
June 19, 2024
PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.
June 18, 2024
The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.