A humanized monoclonal antibody that targets CD19+ B cells becomes the first and only FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.
Researchers found that seven days of antibiotics is likely noninferior to 14 days for Gram-negative bloodstream infections, supporting shorter treatment durations.
The FDA has granted accelerated approval to Vanrafia (atrasentan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression.
March’s FDA approvals feature new biosimilars, first-in-class therapies, expanded indications, and diagnostic innovations across allergy, cardiology, gastroenterology, infectious diseases, and more.
New research reveals 25% tariffs on Canadian pharmaceuticals would impact critical medications, strain supply chains, and potentially increase costs—with 28 drugs having no alternative suppliers.
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FDA approves gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urinary tract infections in females aged 12 and older, based on phase III trial results.
The researchers found that invasive urodynamic testing did not improve outcomes or cost-effectiveness in women with refractory overactive bladder symptoms.
The FDA approves vutrisiran (Amvuttra) as the first RNAi therapeutic to reduce cardiovascular events and mortality in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.