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. https://www.businesswire.com/news/home/20180914005613/en/Teva-Announces-U.S.-Approval-AJOVYTM-fremanezumab-vfrm-Injection 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). http://news.ironwoodpharma.com/news-releases/news-release-details/ironwood-pharmaceuticals-announces-fda-fast-track-designation The FDA has cleared Mersana Therapeutics to resume enrolling[…]