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Following a safety review, the FDA has added additional warnings to the labels of SGLT2 inhibitors for diabetes because they can cause the body to produce too much acid in the blood or lead to serious urinary tract infections. Read More
India is giving drug exporters some breathing space on track-and-trace requirements, with the length of the delay depending on the size of the operation. Read More
Merck has agreed to pay $830 million to settle claims that it failed to inform investors of the heart risks related to its Vioxx pain medication, which is now discontinued. Read More
The U.S. Supreme Court has refused to hear Johnson & Johnson’s appeal of an unfavorable ruling in a negligent labeling case, a decision that will cost the company $140 million. Read More
While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released Thursday. Read More