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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
Teva Pharmaceuticals is getting ready to divest assets in anticipation of regulatory objections to its purchase of Allergan’s generics division, according to a corporate filing. Read More
Amid increased scrutiny over drug pricing, Mylan has been hit with a subpoena from the antitrust division of the Department of Justice over pricing of its 50-year-old antibiotic doxycycline, the drugmaker revealed in an SEC filing. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More