U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The U.S. Food and Drug Administration approved Xeris Pharmaceuticals Inc.’s glucagon pen Gvoke, which aims to treat severely low sugar levels in diabetes patients.
A high dose of Amarin Corp.’s omega-3 drug Vascepa significantly reduced the occurrence of first and subsequent heart attacks, strokes and other serious heart problems in high-risk patients already taking cholesterol medication by even more than initially reported, according to data.
A second patient died in a late-stage trial of Zafgen Inc’s experimental obesity treatment, highlighting safety concerns associated with drugs that aim to treat a condition that affects one in three Americans. Shares of Zafgen tumbled more than 50 percent to $8.00 in premarket trading on Wednesday. The company said a patient receiving its drug, […]