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The April 2026 FDA action removes them from the Category 2 restricted compounding list effective April 23, 2026, and the FDAs Pharmacy Compounding Advisory Committee will review their compounding eligibility under 503A at its July 23-24, 2026 meeting
The GLORY-1 trial used 4 mg and 6 mg maintenance doses
Ubiquitin-positive inclusion bodies and the loss of dopaminergic neurons have been observed in the substantia nigra of UCHL I93M transgenic mouse brains (Setsuie et al., 2007)
12 Cardiolipin membranes are delicate and susceptible to oxidative damage
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