Health care investor Water Street Healthcare Partners reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for cardiovascular medication Bivalirudin in 0.9% Sodium Chloride Injection (bivalirudin) following its strategic partnership with a medical products company.
The US FDA approval of bivalirudin marks the fifth drug product successfully developed by Water Street's company, Celerity Pharmaceuticals LLC.
The company said bivalirudin is the first presentation in a frozen, premixed, ready-to-use formulation.
In conjunction, Celerity both funded and led the development and approval of bivalirudin through its strategic partnership with the medical products company.
Upon the US FDA approval of bivalirudin, Celerity transferred ownership to its partner, which will commercially launch the new product in the US.
Bayer and Broad Institute extend cardiovascular research alliance to advance precision therapies
CirCode Biomed's IND application for HM2002 receives FDA clearance
CeleCor Therapeutics completes Phase 3 trial of new anti-platelet agent for heart attack
Sarepta receives UK approval to continue dosing in ELEVIDYS ENVISION study
Ionis reports positive Phase 3 results for olezarsen in moderate hypertriglyceridemia
Nordic Bioscience launches new Endotrophin assay
AbbVie and ADARx Pharmaceuticals partner on next-generation siRNA therapies
Otsuka's leukaemia drug ponatinib launched on Fangzhou platform
FDA accepts Novo Nordisk's filing application for oral semaglutide 25 mg
Avacta Therapeutics reports positive Phase 1 data for lead candidate
Innovent's limertinib receives Chinese regulatory approval for first-line treatment of lung cancer
Primo Biotechnology's Taoyuan facility granted PIC/S GMP Certification
Renibus Therapeutics completes RBT-1 Phase 3 clinical trial enrolment