Top Regulatory News Stories – Week Ending April 27, 2018

The FDA has approved Helsinn’s intravenous formulation of AKYNZEO® (a fixed antiemetic combination of fosnetupitant and palonosetron) as an alternative treatment option for patients experiencing Chemotherapy Induced Nausea and Vomiting.  Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014. https://www.helsinn.com/news-and-events/helsinn-group-announces-the-fda-approval-of-the-iv-formulation-of-akynzeo-fosnetupitant-palonosetron-in-the-united-states/ Catalyst Pharmaceuticals announced its submission of a NDA[…]