FDA approval of a generic pomalidomide formulation; confirms bioequivalence to reference but does not report clinical efficacy or comparative trial data.
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FDA approval of a generic pomalidomide formulation; confirms bioequivalence to reference but does not report clinical efficacy or comparative trial data.
APR 27, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide; this is a regulatory action, not a clinical evidence assessment.
APR 27, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide generic formulations; this is a regulatory action, not clinical evidence of efficacy or safety.
APR 27, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide; establishes regulatory requirements but does not report clinical efficacy or safety trial outcomes.