Philippine health officials investigating the anti-dengue vaccine Dengvaxia announced Friday that the drug may be linked to the deaths of three children. Read More

The FDA issued a black box warning for Ocaliva (obeticholic acid), a liver disease medication that was incorrectly dosed as daily instead of weekly for patients with primary biliary cholangitis (PBC), increasing the risk of serious liver injury and worsening liver problems. Read More

The European Medicines Agency released a draft revised guideline for safety and efficacy follow-up of advanced therapy medicinal products, including gene therapies, cell therapies and tissue engineering. Read More

The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More

Dr. Reddy’s agreed to pay $5 million to settle claims it sold products without sufficient safety testing of the packaging. Read More

Three South Dakota tribes sued two dozen drugmakers including Allergan, Teva and Purdue alleging the companies violated the Racketeer Influenced and Corrupt Organizations (RICO) act and engaged in fraud and deception in pushing their opioid products. Read More

The FDA is mandating a new class warning and labeling changes for all gadolinium-based contrast agents — as well as requiring manufacturers to conduct additional human and animal safety studies. Read More

The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects. Read More