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Roche has announced the initiation of the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C.
AstraZeneca announced that the FDA has approved a new indication for the company's proton pump inhibitor Nexium (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome.
The FDA has approved the use of Genentech's Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small-cell lung cancer.
La Jolla Pharmaceutical has requested the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Riquent (abetimus sodium), its drug candidate for lupus renal disease.
MGI Pharma announced it has received an approvable letter from the FDA for Saforis (glutamine) Powder in UpTec for Oral Suspension, an investigational therapy for the treatment and prevention of oral mucositis, a common side effect of mucotoxic cancer therapy.
Indevus Pharmaceuticals has submitted a new drug application (NDA) to the FDA seeking approval for Sanctura XR to treat patients with overactive bladder.
Solvay Pharmaceuticals and Wyeth announced hat a new drug application (NDA) has been submitted to the FDA for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia.
Alnylam Pharmaceuticals announced that it has initiated a Phase I human clinical trial of an inhaled formulation of ALN-RSV01 in the U.S. to evaluate its safety, tolerability and pharmacokinetics in healthy adult volunteers.