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The FDA has approved the use of Plavix (clopidogrel bisulfate) for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair.
Alantos Pharmaceuticals has initiated a Phase I study of ALS 2-0426, an orally active, small-molecule inhibitor of Dipeptidyl Peptidase IV (DPP-IV) for the treatment of Type 2 diabetes.
Tibotec Pharmaceuticals presented 48-week efficacy and safety data on TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI), at the Internationals AIDS conference in Toronto.
Omrix Biopharmaceuticals announced it will begin a Phase III open-label, single-arm, multicenter clinical trial for treatment of primary immune deficiency with Omr-IgG-am, the company's intravenous immunoglobulin (IVIG) currently marketed outside of the U.S.
Serono announced results of a Phase III trial of its recombinant human growth hormone (r-hGH) for the treatment of HIV-associated adipose redistribution syndrome (HARS) at the International AIDS Conference in Toronto.
Join FDAnews Wednesday, Aug. 30, for "Reduce FDA Restrictions on Scheduled Products: How to Develop Effective RiskMAPs as Part of the NDA." In this 90-minute interactive audioconference, Edgar Adams, Sc.D., executive director of epidemiology, Late Stage Development Services Unit, Covance, helps you discover how to apply "worst case" scenarios so that you can significantly reduce risks for your scheduled products. On Aug. 31, join FDAnews for "Reduce Supply Chain Risks: How the FDA Expects You to Manage Outsourced Suppliers." In this 90-minute audioconference with Q&A session, Martin Browning, founder and president of EduQuest and a former top FDA investigator, tells you how to navigate unexpected liabilities and legal and regulatory responsibilities.