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The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
Days after the European Medicines Agency launched an investigation into Gilead’s Zydelig, the agency’s Pharmacovigilance Risk Assessment Committee now is recommending the drug be taken with antibiotics to prevent pneumonia. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
Small drugmaker Fabre-Kramer Pharmaceuticals won a big victory Thursday after the FDA ignored its own internal advisory committee recommendations and negative determinations by the Office of New Drugs’ Office of Drug Evaluation I. Read More
The FDA put a damper on Eagle Pharmaceuticals’ plans to market its blood thinner Kangio via a complete response letter not recommending approval. Read More