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...
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.
