Top Regulatory News Stories – Week Ending September 21, 2018

Teva announced U.S. FDA approval of AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. Ironwood Pharmaceuticals announced that the FDA has granted Fast Track Designation for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). The FDA has cleared Mersana Therapeutics to resume enrolling[…]