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FDA regulation

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Pharma & Biotech

Can Idorsia Pharmaceuticals Ltd’s lucerastat redefine Fabry disease treatment beyond enzyme replacement therapy?

Discover how Idorsia Pharmaceuticals Ltd’s FDA-aligned Phase 3 plan could make lucerastat the first oral therapy for all Fabry disease patients. Read the analysis.

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Pharma & Biotech

Imviva Biotech secures FDA orphan designation as CD7 CAR-T development faces execution challenges

FDA grants orphan drug designation to Imviva Biotech’s CTD402. Find out what this means for allogeneic CAR-T development in T-cell leukemia.

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