Top Regulatory News Stories – Week Ending July 20, 2018

Agios Pharmaceuticals said the US FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year. https://www.biospace.com/article/agios-pharmaceuticals-scores-fda-approval-for-tibsovo-second-aml-drug-win-in-less-than-a-year/ SIGA Technologies announced that the FDA approved its filing for oral TPOXX (tecovirimat) as the first therapy with an indication specifically for the treatment of smallpox “to mitigate the[…]