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 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.
In a phase 3 RCT of children aged 3 to 17 years with achondroplasia, once-daily oral infigratinib significantly increased annualized height velocity vs placebo at 52 weeks.
In a phase 3 randomized controlled trial of adults with active IgG4-related disease, weekly subcutaneous obexelimab significantly prolonged time to first flare requiring rescue therapy vs placebo and...
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 sacituzumab govitecan-hziy (Trodelvy) as monotherapy, and with pembrolizumab-based therapy, for select adults with previously untreated unresectable locally advanced or metastatic...
