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News Digest / Lukas Schmidt

Author: Lukas Schmidt
07:31am, Monday, Oct 06, 2025
GSK to File Leucovorin Autism Label After FDA's ~40‑Case Review - 4-6 Month Fast‑Track Could Lift Sales, Squeeze Hikma
FDA asks GSK to refile branded leucovorin for cerebral folate deficiency, fast‑tracking a label change that could boost prescriptions and generic sales (Hikma). Traders watch insurer coverage and a precedent for quicker repurposing.
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