Day: August 27, 2026

Translating cutting-edge cell and gene therapies (CGTs) from early bench concepts to commercial realities presents a complex regulatory landscape. FDA’s latest FAQ guidance adds to its previous suggestions regarding regulatory interactions, chemistry, manufacturing, and controls (CMC), nonclinical evaluation, and clinical design. For sponsors navigating regulatory hurdles, this guidance provides an operational blueprint to clarify agency … Read more

Developing active immunotherapy products (ACTIMPs) has long presented a unique bioanalytical bottleneck because therapeutic efficacy relies on complex host immune responses rather than straightforward direct activity. For years, drug developers have wrestled with static legacy testing expectations that fail to accommodate multi-antigen vectors, cellular matrices, or patient-specific neoantigen vaccines. The FDA’s new guidance outlines a … Read more