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- FDA issues warning letters to drug manufacturers in India, China and US over GMP violationsThe FDA has sent formal warning letters to several companies located in India, China and the United States. The letters cite multiple breaches of current good manufacturing practice standards in t…
- 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,…