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The FDA has placed clinical trials for California-based biotech Geron’s blood cancer candidate, imetelstat, on hold after liver abnormalities were found in study subjects. Read More
The drugmaker says this is the first randomized trial of an angiogenic agent in combination with a vascular disrupting agent, but no chemotherapy. Read More
The European Medicines Agency (EMA) on Tuesday launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More
The Centers for Medicare & Medicaid Services (CMS) has backed away from its controversial plan that would have removed protected status for antidepressants and immunosuppressants in formularies under Medicare Part D. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
FDA efforts to standardize capsule and tablet sizes for generic drugs are unnecessary and will strain relationships with suppliers, generic drugmakers say. Read More
The White House on March 4 proposed increasing funding for the FDA in fiscal 2015 by eight percent above fiscal 2014, a slight bump that includes a $6 million increase in GDUFA user fees. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
Beginning with the 2015/2016 flu season, drugmakers producing vaccines in the EU to protect against annual flu strains will not need to conduct preapproval clinical studies to support vaccine applications. Read More
An FDA report using new data collection methods shows that more drugs than previously thought need to meet their postmarketing requirements and postmarketing commitments, which include Phase IV clinical trials. Read More