ParagonRx® | Minimize Risk and Optimize Use

Reacting to a death associated with the multiple sclerosis drug fingolimod (Gilenya), the FDA said patients with certain cardiac risk factors should not take the oral agent...

The interleukin (IL)-1 inhibitor rilonacept (Arcalyst) reduces the number of acute gout flares during the vulnerable period while treatment with allopurinol is being started, FDA reviewers found, but they called the drug's safety into question because of an increased risk of malignancy...

The U.S. Food and Drug Administration earlier today issued an extensive update regarding the risk of developing a second cancer while being treated with Revlimid...

The U.S. Food and Drug Administration thanks the Institute of Medicine (IOM) for its thoughtful insights and recommendations in its report titled, Ethical and Scientific Issues in Studying the Safety of Approved Drugs. We are encouraged to see that many of the IOM’s recommendations align favorably with current FDA programs and processes, and with our plans for further refinements in how we ensure that marketed drugs are safe and effective for the American public...

First-time abusers of prescription painkillers such as OxyContin most often get the drugs for free from friends or family, while chronic abusers seek doctors or dealers to get their fix, a new federal analysis finds...

Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) recently announced the availability of their type II diabetes treatment, Bydureon (exenatide once-weekly) in the US...

Bayer HealthCare is working with the Ludwig Boltzmann Institute (LBI) for Lung Vascular Research in the research area of lung vascular diseases - especially pulmonary hypertension...