Remove 2028 Remove Clinical Research Remove Pharmacokinetics Remove Trials
article thumbnail

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. As AgencyIQ discussed in-depth at the time , the committee grappled with data flaws and gaps within the context of positive trials and high unmet need.

FDA 40
article thumbnail

Improving quality control for CAR T cell therapies

Drug Discovery World

In 1987, researchers developed the chimeric antigen receptor (CAR) as an alternative means to identify cancer cells and direct T cells to attack them. And now, with more than 600 CAR T trials recruiting or ongoing, these cells represent a majority of the cellular immunotherapies in development today. Training T cells to target tumours.

Therapies 246