Top Regulatory News Stories – Week Ending February 9, 2018

The FDA on Wednesday approved Biktarvy, Gilead Sciences’s once-daily, triple-combination tablet for treatment of HIV infection Spectrum Pharmaceuticals plans to file a BLA for approval of its chemotherapy side effect drug Rolontis later this year based upon positive results from a Phase 3 study Zogenix has won the FDA’s breakthrough therapy designation for[…]