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Eight Democratic senators have sent a letter to the FDA, airing their concerns over the effects of the government-wide hiring freeze on the agency’s mission. Read More
The FDA and other government agencies are being ordered to identify two regulations to be eliminated for each new one they propose and to reconsider the industry’s costs of compliance, according to an executive order issued by President Donald Trump. Read More
Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic Cipro. Read More
The U.S. Court of Appeals for the Federal Circuit affirmed Cumberland Pharmaceuticals’ patent for its second-generation version of Acetadote, barring Mylan from marketing a generic of the overdose therapy. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars. Read More
The FDA had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump Administration directed agencies to halt correspondence with members of Congress. Read More