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Conclusions Subcutaneous infusion using a subcutaneous catheter system and a portable pump for OHCbl administration in combined and isolated remethylation disorders is safe, acceptable, and effective

FDA staff have already recommended against adding them to the permanent 503A list

Diet and Lifestyle: In conjunction with injections, dietary adjustments or oral supplementation may be considered to maintain adequate vitamin B12 levels, especially in dietary-related deficiencies

STAT News reported that FDA has withdrawn its objection to UniQure's Huntingtons disease drug AMT-130, clearing the path for the company to file an accelerated approval application in the third quarter of 2026