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- Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' PluvictoCurium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
- FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detectedThe FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…