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Threshold Pharmaceuticals announced that under the FDA has granted orphan drug designation to the company's product candidate, glufosfamide, for the treatment of pancreatic cancer.
Human Genome Sciences (HGS) has announced that the results of a Phase I clinical trial of HGS004 (CCR5 mAb) demonstrate that it was well-tolerated and exhibited antiviral activity in patients who are infected with HIV-1.
Allos announced that the FDA has granted fast-track designation to the company's unique next-generation antifolate PDX (pralatrexate) for the treatment of patients with T-cell lymphoma.
Cytokinetics announced results from a planned interim analysis following Stage 1 of a two-stage Phase II clinical trial of ispinesib administered as monotherapy in the treatment of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (RMHNSC).
Roche announced that the latest results from an international, Phase III study showed the chemotherapy combination XELOX (Xeloda plus oxaliplatin) to be as effective -- in terms of progression-free survival (PFS) -- as the current standard treatment, FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin), in the treatment of advanced (metastatic) colorectal cancer.
Lupin Pharmaceuticals has announced that the FDA granted final approval for its abbreviated new drug application (ANDA) for lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg.
Genentech and Biogen Idec announced that the FDA has approved two additional uses for Rituxan (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL).
The FDA has approved Duodote (atropine and pralidoxime chloride injection) for use by trained emergency medical services personnel to treat civilians exposed to life-threatening organophosphorus-containing nerve agents, such as sarin, and insecticides.