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 FDA has approved rilzabrutinib (Wayrilz) as the first Bruton’s tyrosine kinase inhibitor for adults with chronic or persistent immune thrombocytopenia who have had an insufficient response to prior therapy.
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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.
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.