REGENXBIO receives FDA response for RGX-121 application
The FDA accepted the gene therapy’s application under the accelerated approval pathway in May 2025. The CRL indicated that the FDA agreed in principle with the study protocol
Amberstone Biosciences has signed a partnership and licence agreement with Shanghai Henlius Biotech for conditionally activated T-cell engager candidates to treat solid tumours.
The designation covers adults with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutant, hormone receptor positive, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression after treatment with