The approval provides a treatment option for adults and adolescents with warm autoimmune hemolytic anemia who are currently or were previously treated with corticosteroids.
The FDA approved the first-in-class targeted therapy based on a clinical trial evaluating overall survival among adults with previously treated metastatic pancreatic adenocarcinoma.
The FDA approved an mRNA-based influenza vaccine mFLUSIVA for adults aged 50 years and older, with accelerated approval applying to adults aged 65 years and older.
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.
...
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.
