The FDA approved Bildyos and Bilprevda are providing new options comparable to Prolia and Xgeva for osteoporosis, cancer-related bone disease, and other skeletal conditions.
The agent was approved by the FDA today for adults with unresectable or metastatic nonsquamous NSCLC whose tumors have HER2 tyrosine kinase domain (TKD)–activating mutations, as detected by an FDA-app...
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.
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A humanized monoclonal antibody that targets CD19+ B cells is first FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.
The FDA has approved Zynyz (retifanlimab-dlwr) as the first programmed death receptor-1 inhibitor for first-line treatment of advanced squamous cell carcinoma of the anal canal.