India, Aug. 27 -- SL Science Holding Limited (SLBT), a biomedical company, on Thursday announced filing a new Master Drug File (MDF) with the U.S. Food and Drug Administration (FDA) to cover exosomes derived from Gamma Delta T (GDT) cells.
A DMF streamlines future regulatory processes by providing the FDA with confidential chemistry, manufacturing, and controls (CMC) data that can be referenced in subsequent applications. The DMF number 044612 for the exosomes was filed by JY BioMed Co Ltd, an investor of the company and the holder of intellectual property (IP) rights for GDT.
GDT technology is being developed for the treatment of solid tumors, such as pancreatic and brain cancers.
Extracellular vesicles like exosomes hold potential for ...