Latest Discovery Labs Stories
WARRINGTON, Pa., Nov. 8, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that new data supporting AFECTAIR(TM), the Company's newest product candidate, was presented at the American Association for Respiratory Care (AARC) Congress 2011, internationally recognized as the most relevant medical meeting dedicated to advancing the science and practice of respiratory care. AFECTAIR has been developed by Discovery Labs to simplify the delivery of inhaled therapies...
WARRINGTON, Pa., Oct. 18, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) today reported that, in a recently published study in the Journal of Neonatal-Perinatal Medicine, nearly all neonatologists (92 percent) interviewed stated they were concerned about the exposure of newborn children to animal-derived medications. Additionally, two-thirds of parents with children in the neonatal intensive care unit (NICU) who were interviewed in the same study wanted to be informed if...
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., Nov. 4, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), reports that, as of the close of business on November 3, the U.S. Food and Drug Administration (FDA) had not yet notified Discovery Labs regarding the target action date and review classification of its Complete Response to the May 2008 Approvable Letter for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Taking FDA guidelines into...
WARRINGTON, Pa., Oct. 17, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today submitted its Complete Response to the May 2008 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA's guidelines provide that by October 31, the FDA will determine the classification of the submission and notify Discovery Labs of its target date for potential...
WARRINGTON, Pa., Sept. 24, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that it has achieved technical success in addressing the 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. Discovery Labs is completing the remaining activities and finalizing the information for its Complete Response to...
WARRINGTON, Pa., Sept. 3, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that its proprietary, aerosolized KL-4 surfactant has been selected for a Phase 2a clinical trial in patients with Cystic Fibrosis (CF). The trial is being conducted as an investigator-initiated study under the direction of Dr. Scott H. Donaldson at The University of North Carolina and is funded primarily through a grant provided by the Cystic Fibrosis Foundation. The trial is designed as...
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...
WARRINGTON, Pa., July 29, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announces the publication in Pediatric Research of data from a pre-clinical research study conducted at the Nemours Research Lung Center, DuPont Hospital for Children. The data showed that KL-4 surfactant reduced the inflammatory response and improved cell survival and function in a human lung cell-culture injury model. Pediatric Research is a prominent peer reviewed journal that publishes results...
WARRINGTON, Pa., June 19, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on June 18, 2008 with the U.S. Food and Drug Administration (FDA) to discuss Discovery Labs' approach to addressing key remaining items identified in the May 1, 2008 Approvable Letter to potentially gain U.S. marketing approval of SURFAXIN(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs received clarification on its...
