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2 developments in the corpus
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JUL 29, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing generic drug; this is a regulatory action, not clinical evidence of efficacy or safety.
JUL 29, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil; a regulatory action without clinical trial data or efficacy assessment.