The approval provides a treatment option for adults and adolescents with warm autoimmune hemolytic anemia who are currently or were previously treated with corticosteroids.
August 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...
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 a once-monthly autoinjector for Lerochol (lerodalcibep-liga) and added language to the prescribing information noting that cardiovascular outcomes trials with statins and monoclonal...
The FDA granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for adults with multiple myeloma previously treated with a proteasome...
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 approved subcutaneous isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis US LLC) for multiple myeloma treatment regimens across relapsed, refractory, and newly diagnosed disease settings.
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.
...
