FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer
Transcenta Holding Limited has announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Osemitamab (TST001), a highly potent humanized monoclonal antibody that enhances ADCC (antibody-dependent cell-mediated cytotoxicity), for treating pancreatic cancer patients. This marks the second time Osemitamab (TST001) has received Orphan Drug Designation, with its first designation being in 2021 for treating gastric cancer and gastroesophageal junction cancer.
Orphan drugs are intended for the prevention, treatment, and diagnosis of uncommon diseases. The US FD...