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.
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The FDA approved gedatolisib with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected after...
The FDA approval provides physicians with a once-daily oral PCSK9 inhibitor option to reduce LDL-C in adults with high cholesterol, including those with heterozygous familial hypercholesterolemia.
The FDA approval expands the use of marstacimab-hncq (Hympavzi; Pfizer Inc.) for routine prophylaxis to prevent or reduce bleeding episodes in additional pediatric and inhibitor-positive hemophilia A and B...
