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In a letter sent Tuesday to President Trump, 11 Senate Democrats urged the White House to scrap plans for fiscal 2018 budget cuts that would affect implementation of the 21st Century Cures Act. Read More
The FDA has issued a boxed warning for Johnson & Johnson’s Invokana (canagliflozin) treatment for type 2 diabetes, describing a doubled risk of leg and foot amputations compared to placebo. In 2016, Invokana brought in more than $1.4 billion in sales. Read More
An FDA investigation into serous quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Read More
The FDA’s new commissioner, Scott Gottlieb, addressed the agency’s full staff for the first time May 15 and highlighted the agency’s key role in combating the opioid crisis. Read More