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bivalirudin

Generic: BIVALIRUDIN·Brand: ANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN, BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

bivalirudin: developed by 1 company · 1 FDA decision.

bivalirudin evidence translation

What we can confirm

What it means

Source-backed records connect bivalirudin to MAIA; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could bivalirudin → MAIA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (2)
CompanyPhase
MAIA Biotechnology, Inc. (MAIA)Approved
MAIA Biotechnology, Inc. (MAIA)Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-indu(MAIA)FDA ↗
NDA211215Type 5 - New Formulation or New ManufacturerStandardIntravenousSolution

Frequently asked questions

Who is developing bivalirudin?

bivalirudin is being developed by MAIA Biotechnology, Inc..

What is bivalirudin's latest FDA decision?

The most recent tracked FDA decision for bivalirudin is Approval for 1 INDICATIONS AND USAGE Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-indu, dated July 25, 2019.