For Discovery Laboratories, the fifth try proved the charm. FDA regulators have finally stamped an approval on Surfaxin as a guard against respiratory distress syndrome in infants after four rejections spread out over an 8-year regulatory odyssey.
Discovery Labs ( $DSCO ) has finally gained FDA approval for Surfaxin, a surfactant treatment for respiratory distress syndrome in infants that's delivered through an endotracheal tube. The positive regulatory news is long awaited, capping an 8-year series of setbacks over the drug's stability and release mechanisms.
Discovery Labs ($DSCO) envisions a late 2012 commercial launch in both the U.S. and Europe of its Afectair ventilator drug delivery system, assuming manufacturing timelines stick and European
Discovery Laboratories has chosen W. Thomas Amick as its next CEO. Amick has been interim CEO since August 2009. Last year, the FDA rejected Discovery's application for Surfaxin as a treatment for an
Discovery Labs ( NASDAQ: DSCO ) says preliminary data shows that its troubled lead drug Surfaxin failed a Phase II study. In fact, Surfaxin looked very much like a placebo in a trial that was aimed at
Shares of Discovery Laboratories (DSCO) climbed this morning after the developer announced that it had been able to validate a test of the quality and stability of its lung drug Surfaxin. A little
Shares of Discovery Labs (DSCO) shot up 10 percent this morning after the developer announced that it would only need to conduct new animal studies of its experimental therapy Surfaxin for
Shares of Discovery Laboratories ( DSCO ) shot up 49 percent this morning after the Warrington, PA-based developer reported that the FDA termed its approach to resolving the agency's primary issue with
Shares of Discovery Laboratories got a much needed boost after the developer announced plans for a sit-down with FDA regulators over the possibility that a limited trial could supply the agency with
Discovery Labs announced Thursday the resignation of Robert Capetola, its CEO since the company's founding 13 years ago. Board Chairman Thomas Amick, a Johnson & Johnson alum, has been appointed