Latest SURFAXIN Stories
WARRINGTON, Pa., April 15, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the U.S. Food and Drug Administration (FDA) has requested clarification and provided recommendations regarding the recently-updated product specifications for SURFAXIN(®). Discovery Labs plans to provide a response to the FDA within two months. FDA procedure provides up...
WARRINGTON, Pa., March 29, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the release of two peer-reviewed publications related to SURFAXIN(®) (lucinactant) Intratracheal Suspension. SURFAXIN, currently the only FDA approved synthetic alternative to animal-derived surfactants in the U.S., was highlighted in the December issue of the Journal of...
WARRINGTON, Pa., Feb. 13, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has entered into a secured loan facility with Deerfield Management Company, L.P. (Deerfield) for up to $30.0 million in financing. Deerfield is a leading healthcare investment firm with more than $3.5 billion of assets currently under management. "We are...
WARRINGTON, Pa., Jan. 4, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced changes to its board of directors and appointed a new Chief Executive Officer (CEO). The following changes are effective immediately: W. Thomas Amick, age 70, has resigned as Chairman of the board of directors and CEO. Mr. Amick served on the board since March 2004, was...
WARRINGTON, Pa., Oct. 24, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today reports a commercial update for SURFAXIN(®) and AFECTAIR(®). The Company has initiated commercial launch activities for both products by training and deploying its newly-formed commercial and medical affairs organizations with the goal of securing hospital formulary acceptance for...
WARRINGTON, Pa., Sept. 28, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) announced today that the U.S. Food and Drug Administration (FDA) has deemed "complete" the company's Complete Response for SURFAXIN® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act...
WARRINGTON, Pa., Sept. 6, 2011 /PRNewswire/ -- Discovery Labs, Inc. (Nasdaq: DSCO) today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the U.S. Food and Drug Administration (FDA) for SURFAXIN® (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery Labs believes that the FDA will designate the Complete Response as a Class 2 resubmission of the SURFAXIN New Drug...
WARRINGTON, Pa., Aug. 6, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that it has made significant progress in addressing key remaining requirements identified by the U.S. Food and Drug Administration (FDA) to gain marketing approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Over the upcoming weeks, Discovery Labs will continue to conduct and finalize activities necessary to submit a Complete...
