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.
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
International researchers have identified a specific antibody mutation that causes rare but serious blood clots after adenovirus-based COVID-19 vaccines or natural adenovirus infection, providing a roadmap for safer vaccine design.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
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Multi-Omics-Based Novel Thrombosis and Bleeding Markers and Risk Model for CHD |
RECRUITING | |
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ACTIVE_NOT_RECRUITING | |
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RECRUITING |
