Grifols has launched FESILTY (fibrinogen, human-chmt) in the U.S., a fibrinogen concentrate FDA-approved in December 2025 for acute bleeding episodes in patients with congenital fibrinogen deficiency. The highly purified product, developed by Biotest, enables rapid fibrinogen restoration and can be reconstituted in approximately three minutes.
Arrowhead Pharmaceuticals presented long-term data showing plozasiran achieved 83% median triglyceride reduction in severe hypertriglyceridemia patients with no acute pancreatitis events over two years. The RNA interference therapy demonstrated durable improvements in atherogenic lipoproteins and consistent safety profile. The company plans to complete Phase 3 studies by mid-2026 and submit for regulatory approval.
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
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