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FDA unveiled April 6 the new Combination Products Policy Council, which will have decision-making authority on issues relating to combination products, cross-labeled products and medical product classification. Read More
It took Pfizer and Allergan less than 48 hours to nix their plan to build one of the world’s largest drugmakers, placing the blame squarely on the U.S. Treasury Department. Read More
A final batch of biomedical innovation bills sailed through markup during a meeting of the Senate HELP Committee Wednesday, as lawmakers work toward passing a companion to the House’s 21st Century Cures Act this session. Read More
Following a safety review, the FDA has decided to add warnings to the labels of Type 2 diabetes drugs containing saxagliptin and alogliptin due to the increased risk of heart failure in patients with kidney or heart disease. Read More
Two compounding operations are facing FDA allegations for producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
The largest drug merger of all time could be at risk of falling through after the U.S. Treasury Department late Monday issued a set of regulations that reduce the benefit of tax inversion deals. Read More