October 17, 2025
Clinical Updates
Libtayo® (cemiplimab-rwlc) – New indication
October 8, 2025 - Regeneron announced the FDA approval of Libtayo (cemiplimab-rwlc), for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
Clinical Updates
Olpruva® (sodium phenylbutyrate) – Updated indication
October 10, 2025 - The FDA approved Zevra Therapeutics’ Olpruva (sodium phenylbutyrate), as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients 1 year of age and older who weigh 7 kg or greater with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Clinical Updates
Rinvoq® (upadacitinib) – Updated indications
October 13, 2025 - AbbVie announced the FDA approval of Rinvoq (upadacitinib), for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of Rinvoq and moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of Rinvoq.
Clinical Updates
Simponi® (golimumab) – Expanded indication
October 7, 2025 - J&J announced the FDA approval of Simponi (golimumab), for the treatment of adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC).
Clinical Updates
Uzedy® (risperidone) – New indication
October 10, 2025 - Teva Pharmaceuticals announced the FDA approval of Uzedy (risperidone), as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Drug Approvals
Lasix® Onyu (furosemide) – New drug approval
October 8, 2025 - SQ Innovation announced the FDA approval of Lasix Onyu (furosemide), for the treatment of edema in adult patients with chronic heart failure.
Drug Recalls - Availability
Trividia Health – Recall of Good Neighbor Pharmacy True Metrix® Self-Monitoring Blood glucose meters
October 7, 2025 - Trividia Health announced a voluntary, consumer level recall of one lot of True Metrix Self-Monitoring Blood Glucose Meters, co-branded under Good Neighbor Pharmacy® because of the potential for defective LCD displays that can affect product performance.