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A joint FDA advisory committee recommendation of narrower indications for, and increased warnings on, sanofi-aventis' antibiotic Ketek has the company taking steps to respond as a competitor may begin grabbing market share.
Generic drugmaker Novopharm, a subsidiary of Israel-based Teva Pharmaceutical, will have to wait at least three years before it can grab a piece of the multibillion-dollar Lipitor market, a court has ruled.
The FDA may be facing increasing pressure on Capitol Hill due to its handling of Ketek, as a former agency official turned whistleblower is working with activists and a key Senate critic to take the FDA to task.
Natren received an FDA warning letter for misleading information on its website and the labeling for its products Gy-Na-Tren Vaginal Health Solution and Life Start.
A European generic trade group expressed doubts over the validity of a new briefing report released early this week by the International Alliance of Patients' Organizations (IAPO), saying it fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.
A bipartisan group of lawmakers is using a recent government report to pressure the Bush administration to increase funding for FDA oversight of direct-to-consumer (DTC) drug advertising and to institute a moratorium on ads for newly approved products.
Clinical trial results for Wyeth's and Solvay's bifeprunox show that the drug maintains stability in patients with stable schizophrenia and improves symptoms in patients with acute schizophrenia, Wyeth announced.
Merck continues to predict growth in its earnings per share (EPS) for 2007, due to high expectations for its new products and savings from a global restructuring plan.