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The EMA is appealing a temporary injunction from the General Court of the European Union that prevents the agency from releasing a clinical study report on PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. Read More
Amgen and UCB announced results from a Phase III trial that showed romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. Read More
The FDA faces a significant number of security vulnerabilities that threaten the confidentiality and integrity of its industry and public health data, a congressional watchdog said. Read More
Lawmakers have called on the Department of Justice to investigate whether Mylan violated the law by misclassifying its severe allergy treatment EpiPen as a generic in the Medicaid Drug Rebate Program. Read More