Top Regulatory News Stories – Week Ending October 12, 2018

The US FDA gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi (inotersen), a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi was previously green-lit in Canada and the European Union. The FDA has approved Leadiant Biosciences’ Revcovi (elapegademase-lvlr) for the treatment of adults and children with[…]