Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.
Public criticism fails to derail approval of Acelrx’s opioid painkiller, but not without a lengthy apologia from Scott Gottlieb.
An expensive cardiovascular programme has proven a dead end, but the Swiss group is already looking towards cancer.
A US complete response letter leaves Ruconest at the mercy of rivals like Shire.
A complete response letter for Waylivra has taken investors by surprise, and increases the pressure on Ionis before an FDA decision on Tegsedi.