The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual …
OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls Read More »
Judge Jesus Bernal ruled in federal court in California’s Central District against the FDA’s argument that a group of stem …
While aging affects most living organisms, the hydrozoan Turritopsis dohrniiis the only species able to rejuvenate repeatedly after sexual reproduction, …
The FDA granted fast track designation to ALLO-316, an investigational chimeric antigen receptor T-cell therapy, for the treatment of adults …
FDA grants fast track designation to donor-derived CAR-T for advanced kidney cancer Read More »
Collection and analysis of real-world data (RWD) continue to gain traction in the biomedical community, accompanied by a growing understanding …
FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future Read More »
As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively …
FDA-EMA Parallel Scientific Advice (PSA) Webinar Read More »
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a public …
