Top Regulatory News Stories – Week Ending September 7, 2018

Merck announced that the U.S. FDA has approved two new HIV-1 medicines:  DELSTRIGO and PIFELTRO:    https://pharmaphorum.com/news/fda-approves-mercks-hiv-treatment/ Tetraphase Pharmaceuticals announced that the FDA has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). https://ir.tphase.com/news-releases/news-release-details/tetraphase-pharmaceuticals-announces-fda-approval-xeravatm Bayer announced that the FDA approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of[…]