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Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says. Read More
In response to criticism surrounding the price of its EpiPen, Mylan plans to sell a generic version of its allergy treatment for half the price. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
The UK’s price watchdog has made it easier for women with uterine fibroids to get non-surgical treatment by endorsing Gedeon Richter’s Esmya product. Read More