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March 18 Product: Orchard Therapeutics Lenmeldy Indication: Metachromatic leukodystrophy Monday, the FDA gave a glimmer of hope to families of children with metachromatic leukodystrophy (MLD), a rare genetic disease affecting the brain and nervous system, with the approval of Orchard Therapeutics Lenmeldy

Deficiency results in fatigue, weakness, and cognitive fog

The ratio of GSH to Glutathione, oxidized is often used to gauge the level of oxidative stress in cells, with higher concentrations of Glutathione, oxidized implying more oxidative stress

Prevention of lipoatrophy: In rare cases, repeated injection can lead to breakdown of subcutaneous fat (lipoatrophy), creating dimples

Early engagement with regulators and alignment on classification criteria will be essential to ensure efficient approval