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The pathway allows companies partnered with a Research Institution to bypass Phase I and move directly to prototype development

Holm Nielsen S, Edsfeldt A, Tengryd C, Gustafsson H, Shore AC, Natali A, et al

an April 2026 removal from that list was procedural (withdrawn nominations and a fresh 503A review) rather than a safety clearance, and the compound stayed unapproved and under regulatory review

The clinicopathological characteristics following GSH treatment were collected and compared with those in Non-GSH group after 1:2 propensity score matching (PSM)

After several washes with distilled water, bands corresponding to PDHc-E2 (~75 kDa) or OGDHc-E2 (~55 kDa) were excised using a sterile scalpel and transferred to Protein LoBind tubes (Eppendorf)