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As cell and gene therapies continue to make headlines as a key opportunity for growth, success in this field will require both innovative tech as well as strategic foresight.
In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applicatio ...
In this guideline, authors address the thorny issues of diagnosis and management of NAIMI, including in pediatric patients and patients who undergo chimeric antigen receptor T-cell therapy.