Day: July 2, 2026

The commercialization landscape for cell and gene therapies (CGT) has historically been restricted by rigid regulatory frameworks designed for traditional biologics. Moving a highly volatile, patient-specific autologous therapy or a low-volume orphan gene vector through a conventional Biologics License Application (BLA) path often felt like forcing a square peg into a round hole. However, the FDA’s May … Read more

In the high-stakes world of drug development, traditional standalone clinical trials increasingly feel like running a marathon in heavy boots. Between soaring costs, competitive recruitment landscapes, and the urgent needs of patients, sponsors are desperately seeking more agile ways to innovate. Enter the FDA’s revised draft guidance on Master Protocols, a regulatory milestone designed to turn multi-study complexity into … Read more