Pediatric safety and pharmacokinetic findings supported expanding leniolisib to children aged 4 to 11 years who weigh at least 27 kg, establishing the first FDA-approved treatment for activated...
Results from the SOHO-01 trial supported expanded use of sevabertinib in adults with HER2-mutated, locally advanced or metastatic nonsquamous non–small cell lung cancer, including patients who had not...
The FDA approval addresses acquired endocrine resistance by allowing eligible patients with HR-positive, HER2-negative advanced breast cancer to switch to camizestrant when an ESR1 mutation is detected in...
Clinical and pharmacokinetic evidence supported approval of zilganersen across pediatric and adult age groups, providing the first therapy designed to reduce production of the abnormal GFAP protein...
A 52-week trial evaluated apitegromab-mstn as an adjunct to SMN2-targeted treatment in patients with spinal muscular atrophy who could not move or walk independently, demonstrating improved motor function...
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.
