August 22, 2025
Clinical Updates
Actemra® (tocilizumab) – Expanded indication
August 8, 2025 - The FDA approved Genentech’s Actemra (tocilizumab), for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Clinical Updates
Wegovy® (semaglutide) – New indication
August 15, 2025 - Novo Nordisk announced the FDA approval of Wegovy (semaglutide), in combination with a reduced calorie diet and increased physical activity, for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.
Drug Approvals
Papzimeos™ (zopapogene imadenovec-drba) – New drug approval
August 15, 2025 - Precigen announced the FDA approval of Papzimeos (zopapogene imadenovec-drba), for the treatment of adults with recurrent respiratory papillomatosis (RRP).
Drug Approvals
Tonmya™ (cyclobenzaprine) – New drug approval
August 15, 2025 - Tonix Pharmaceuticals announced the FDA approval of Tonmya (cyclobenzaprine) sublingual tablets, for the treatment of fibromyalgia in adults.
Drug Recalls - Availability
Celltrion – Recall of Steqeyma® (ustekinumab-stba) injection
August 14, 2025 - Celltrion announced a voluntary, consumer level recall of one lot of Steqeyma (ustekinumab-stba) injection.