The FDA has granted Breakthrough Device designation to Castle Biosciences’ DecisionDx-Melanoma test, a gene expression profile assay designed to improve risk stratification and personalized care in cutaneous melanoma.
Tyzavan is the first FDA-approved vancomycin formulation available at room temperature that requires no compounding, thawing, or dilution, enabling faster treatment in time-critical infections like sepsis.
Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.
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.
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A Phase I study of intrathecal resiniferatoxin in patients with advanced cancer pain shows promising reductions in pain and opioid use, with durable effects and manageable side effects.