July 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approval introduces a nonprescription fixed-dose combination of 2 widely used analgesics for temporary relief of common minor aches and pains in adults and children aged 12 years or older.
The FDA expanded approval of exagamglogene autotemcel (Casgevy) for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia.
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The FDA has approved veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease regardless of disease activity or duration, based on the pivotal phase 3 THRIVE and THRIVE-2 clinical trials.
The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
The FDA approved ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual with COVID-19.
The FDA approved Baxfendy as an adjunctive treatment to lower blood pressure in adults with hypertension not adequately controlled on other antihypertensive medications.
The FDA has approved a supplemental indication for lumateperone to reduce relapse risk in adults with schizophrenia based on phase 3 randomized withdrawal data.
The FDA has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
