FDA approves StemCyte’s cord blood stem cell therapy BLA
The approval makes the company the first commercial biotech to receive such a license for this cell therapy type. Derived from the umbilical cord blood of humans, the
The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The BLA is sought for treating NSCLC patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) who have received systemic therapies previously. Concurrently, the companies have