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Pfizer’s Revatio Injection receives FDA approval

20. November 2009 09:18
Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. [More]

Gentium to present Defibrotide trial data at the ASH meeting

16. November 2009 10:02
Gentium S.p.A. announced today that results from the Company’s Phase II/III Pediatric Prevention trial and Phase III Treatment trial for Defibrotide of Hepatic Veno-Occlusive Disease will be presented at American Society of Hematology Conference (ASH), December 5-8 in New Orleans. [More]

Second-quarter fiscal 2009 results announced by Gentium

17. September 2009 08:13
Gentium S.p.A. (NASDAQ: GENT) today reported financial results for the second quarter ended June 30, 2009. [More]

Gentium reports results from phase 3 trial of defibrotide for severe veno-occlusive disease

19. August 2009 08:30
Gentium S.p.A. has announced top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients. [More]

FDA approves Adcirca (tadalafil) tablets for pulmonary arterial hypertension

26. May 2009 05:40
United Therapeutics Corporation announced today that the United States Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). [More]

Gentium S.p.A. updates on phase 3 trial of Defibrotide for severe veno-occlusive disease

19. November 2008 22:18
Gentium S.p.A. announced today interim results from an independent Data Safety Monitoring Board (DSMB) review of the Company's Phase 3 treatment trial of Defibrotide for Severe Veno-Occlusive Disease (VOD). [More]

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