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The accelerated approval for Eisai and Biogens Leqembi (lecanemab) was converted to a full approval based on results from the confirmatory Clarity-AD trial, which the FDA said in its statement verified the drugs benefit

Preventing Ataxin-3 protein cleavage mitigates degeneration in a Drosophila model of SCA3

GMP contract manufacturers (CDMOs) producing peptide APIs for pharmaceutical use are regulated under FDAs current Good Manufacturing Practice (cGMP) framework and are subject to facility inspections

In the phase 1 study, MariTide showed a weight loss of nearly 15% of initial body weight after 3 months, with results persisting for approximately 5 months after the last dose

however, challenges in delivering GHK-Cu topically limits their non-invasive applications