MDGL CHMP opinion: Thursday, July 23, 2026

Variation type II · Rezdiffra · A grouped application consisting of: C.I.13: Submission of the final report from study MGL-3196-21. This is phase 1, multi-center, open-label study to evaluate the pharmacokinetics, safety, and tolerability of multiple oral doses (6 days) of 100 mg resmetirom in subje

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