Top Regulatory News Stories – Week Ending July 27, 2018

AbbVie received FDA approval for elagolix, the first new oral drug approved for endometriosis pain in more than a decade.  The drug will be rolled out into the marketplace under the name Orilissa.  https://endpts.com/following-some-clean-sweeps-in-phiii-abbvie-gets-an-fda-ok-on-its-top-10-blockbuster-prospect-orilissa/?utm The FDA approved the 12th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible indications[…]