Novartis receives FDA priority review for Coartem , potentially the first artemisinin-based combination treatment ... (n-tv.de)
Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- -------------- * Coartem achieves high cure rates in studies[1],[2] and since 2001 has helped save an estimated 500,000 lives * Priority review by FDA underscores urgency of stopping ...

Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial (Medical News Today)
Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S.