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DOR BioPharma has received clearance from the FDA to conduct a Phase II clinical trial of orBec for the prevention of graft-versus-host disease (GVHD).
CuraGen and TopoTarget have begun patient dosing in a Phase II open-label, multicenter clinical trial evaluating the efficacy and safety of intravenous belinostat (PXD101), a small-molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade in multiple myeloma patients refractory to or who have rapidly relapsed from at least one previous bortezomib-containing regimen.
Dong-A PharmTech announced it has completed a 340-patient, Phase IIb clinical study for udenafil, its new long-acting oral phosphodiesterase type 5 (PDE5) inhibitor for treating erectile dysfunction (ED).
Horizon Therapeutics announced that it has begun its Phase III trial program for HZT-501, a nonsteroidal anti-inflammatory drug (NSAID) for mild-to-moderate pain relief.
Merck and Lundbeck announced they have discontinued their joint development program for gaboxadol, an investigational drug for the treatment of insomnia.
The Medicines Company presented favorable findings on its investigational drug Cleviprex compared with current intravenous (IV) antihypertensive agents in controlling perioperative hypertension at the 56th Annual Scientific Session of the American College of Cardiology.
Mylan Laboratories has announced the approval and launch of its latest first-to-market generic product, ciprofloxacin extended-release tablets in 500- and 1,000-mg strengths.
Roche has submitted a supplemental new drug application (sNDA) to the FDA for the use of Xelox with or without Avastin in the treatment of metastatic colorectal cancer.
Genta announced it has been verbally informed that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) is likely to issue a negative opinion on its application for Genasense to treat advanced melanoma.