Teva Pharms U

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative clinical outcomes.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Sodium (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing immunosuppressant; indicates regulatory action on safety management, not new clinical efficacy evidence.

JUN 26, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Argatroban IN 0.9% Sodium Chloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to an existing argatroban product; regulatory action, not clinical evidence of efficacy or safety.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Morphine Sulfate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release capsules; this is a regulatory action, not a clinical evidence trial.