Top Regulatory News Stories – Week Ending June 27, 2019

AMAG Pharmaceuticals announced that the U.S. FDA has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. https://www.amagpharma.com/news/amag-pharmaceuticals-announces-fda-approval-of-vyleesi-bremelanotide-injection-for-acquired-generalized-hypoactive-sexual-desire-disorder-hsdd-in-premenopausal-women/ Alexion’s drug Ultomiris has snagged a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage[…]