Top Regulatory News Stories – Week Ending May 4, 2018

This was a pretty busy week with an approval of a new molecular entity for Portola, a second indication approval for Novartis’s Kymriah, several new orphan drug designations, and a complete response letter for Sandoz.  Here are the top regulatory news stories for this week: Portola Pharmaceuticals received FDA accelerated approval for once-rejected Andexxa, the[…]