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Eli Lilly received an approvable letter from the FDA for Arxxant (ruboxistaurin mesylate), its investigational oral therapy for treatment of diabetic retinopathy, an eye disease.
ProEthic Pharmaceuticals has announced the results from two Phase I trials for PRO-571, the company's product candidate for the treatment of acute pain.
Poniard Pharmaceuticals has completed enrollment in a Phase II, open-label, multicenter trial evaluating picoplatin for the treatment of small-cell lung cancer.
Schering-Plough has reported that results from an ongoing Phase II clinical
trial showed vicriviroc, its investigational CCR5 receptor antagonist, demonstrated potent and sustained viral suppression after 24 weeks of therapy in 118 treatment-experienced HIV patients, when administered in once-daily doses in combination with an optimized ritonavir-boosted protease inhibitor (PI)-containing antiretroviral regimen.
EpiCept announced that patient enrollment has been completed for its multicenter, randomized, double-blind, placebo-controlled, Phase III trial in Europe for LidoPAIN SP (lidocaine).
Caraco Pharmaceutical Laboratories has announced that the FDA granted final approval for the company's abbreviated new drug application for generic baclofen tablets.
Orchid Chemicals and Pharmaceuticals has received approval from the FDA for three of its abbreviated new drug applications (ANDA) for cefotaxime injection in various dosage forms.
The FDA has approved Cubicin (daptomycin) to combat heart and bloodstream infections brought on by Staphylococcus bacteria, or staph infections. The drug is manufactured by Cubist Pharmaceuticals and was originally approved in 2003 for treating skin infections.