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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Approval status date2026-08-31
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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.
JUL 30, 2026 · REGULATORY APPROVAL
U.S. Food and Drug Administration
FDA approval of a generic fexofenadine hydrochloride formulation; establishes regulatory authorization but does not report clinical trial efficacy or comparative outcomes.
FDA approval of a generic venetoclax formulation; regulatory action confirming bioequivalence and manufacturing standards, not a clinical efficacy trial.
FDA approval of a generic nintedanib formulation; establishes regulatory authorization but does not contain clinical efficacy or safety data.
MAR 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for a REMS (Risk Evaluation and Mitigation Strategy) program for vigabatrin; indicates regulatory action to manage known safety risks but does not report clinical trial data or efficacy.