Max Gelman / endpoints - The FDA has placed a partial clinical hold on MacroGenics’ Phase 2 study in gynecologic cancers after one patient died and three others experienced life-threatening side effects, the company disclosed Tuesday. The patient who died ...
AI Summary: Regulators have imposed a partial hold on a Phase 2 gynecologic cancer trial after multiple serious adverse events, including one patient death and additional safety incidents. The pause mandates review of trial protocols and safety monitoring before enrollment can resume, highlighting the inherent risks when experimental therapies meet human biology.
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