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The FDA has halted PepGen's plan to begin a phase 2 trial for Duchenne muscular dystrophy treatment in the U.S.
The FDA has placed a clinical hold on PepGen's plans to start a phase 2 trial for its Duchenne muscular dystrophy (DMD) treatment, PGN-EDO51, in the U.S.
The company expects to receive a detailed hold letter from the FDA within 30 days.
Despite the hold, the study is already underway in the U.K. PepGen's stock dropped 29% in premarket trading on this news.
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La FDA ha detenido el plan de PepGen de iniciar un ensayo de fase 2 para el tratamiento de la distrofia muscular de Duchenne en los EE.UU.