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Biosyngen’s BRG01 Earns Orphan Drug Designation from US FDA for Nasopharyngeal Carcinoma
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Biosyngen, a leading cell therapy developer based in Guangzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its first-in-class nasopharyngeal carcinoma (NPC) cell therapy, BRG01. BRG01: A Pioneering Cell Therapy for NPCBRG01 is a genetically modified T cell product…
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Biosyngen Receives US FDA IND Approval for T-Cell Redirection Therapy for EBV-Positive Lymphoma
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
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Biosyngen’s BRG01 Gets FDA Nod for NPC Clinical Study
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Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative…
