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RxNews®

Valuable and timely information on drug therapy issues impacting today's health care and pharmacy environment.

August 14, 2026

Drug Recalls - Availability

Fresenius Kabi – Recall of morphine sulfate injection

August 4, 2026 - Fresenius Kabi announced a voluntary, consumer level recall of one lot of morphine sulfate injection, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as morphine 2 mg/1 mL, may contain a prefilled syringe of Dilaudid® (hydromorphone) 0.5 mg/0.5 mL.

Drug Recalls - Availability

Fresenius Kabi – Recall of Tyenne® (tocilizumab-aazg)

August 10, 2026 - Fresenius Kabi announced a voluntary, consumer level recall of one lot of Tyenne (tocilizumab-aazg) injection 400 mg/20 mL (20 mg/mL) because the product was found to contain glass particles.

Drug Approvals

mFLUSIVA® (influenza vaccine, mRNA) – New vaccine approval

August 5, 2026 - Moderna announced the FDA approval of mFLUSIVA (influenza vaccine, mRNA), for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine.

Drug Approvals

Qlonilik® (clonidine) – New drug approval

July 29, 2026 - The FDA approved CMP Pharma’s Qlonilik (clonidine), for the treatment of hypertension, to lower blood pressure in adults.

Drug Approvals

Orzeyful™ (oveporexton) – New orphan drug approval

August 5, 2026 - The FDA announced the approval of Takeda’s Orzeyful (oveporexton), for the treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adult patients.  

Drug Approvals

Tudriqev™ (vusolimogene oderparepvec-wtpg) – New drug approval

August 6, 2026 - The FDA announced the approval of Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg), in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.