Navigation Links
Discovery Labs Notified of PDUFA Date for SURFAXIN®
Date:9/28/2011

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 (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.

If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.

Discovery Labs will hold a conference call today at 3:00 PM EDT to provide an overview of the SURFAXIN Complete Response filed with the FDA.  

Conference Call Details

A live webcast of the conference call, including a slide presentation, is available at https://us.reg.meeting-stream.com/surfaxin-update and www.discoverylabs.com. An archive of the webcast will be available on Discovery Labs Investor Relations web site for approximately 45 days.  

For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the dial-in numbers are (866) 332-5218 (U.S.) or (706) 679-3237 (international). The passcode for the call is 11540927.    

An audio replay of the conference call will be available two hours after the call's completion. The dial-in numbers for the replay are (855)
'/>"/>

SOURCE Discovery Laboratories, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
2. New Company Starts, Bridging the Development Gap in the Discovery of Cancer Drugs
3. Trana Discovery and Southern Research Institute Announce the First RNA-RNA High Throughput Drug Screening Assay Platform for HIV Antivirals
4. ActiveSight and CHDI Leverage Fragment-Based Lead Discovery for Huntington Disease Therapies
5. ARCA Discovery Announces Data Demonstrating Potential for Bucindolol as Targeted Therapy in Heart Failure, Atrial Fibrillation, and Ventricular Arrhythmia
6. Five Clinical Studies to Receive $2.5 Million Under Foundations 2007 Clinical Discovery Program
7. Ambrx Enters FGF-21 Type 2 Diabetes Drug Discovery Collaboration with Merck and Co. Inc.
8. FASgen Announces New Discovery for Treatment of Stroke
9. Nobel Prize-Winning Discovery
10. Orion Genomics Announces the Discovery of Novel Breast Cancer Biomarkers
11. FASgen Announces a New Discovery in Obesity Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/16/2015)... , April 16, 2015  Hologic, Inc. (NASDAQ: ... cancer screening study i published on-line this ... journal of the American Cancer Society. ... the University of Pittsburgh Medical Center, supports current consensus guidelines ... that women 30-65 years of age be co-tested ...
(Date:4/16/2015)... April 16, 2015 Mallinckrodt plc (NYSE: ... today announced that it has completed its acquisition ... approximately $2.3 billion. The Ikaria acquisition extends Mallinckrodt,s ... reach into neonatal critical care with INOMAX ® ... for a highly vulnerable patient population. It also ...
(Date:4/16/2015)... , April 16, 2015  Rosewind Corporation (OTCMKTS: ... reverse merger with a newly formed specialty healthcare ... focus on addressing urological disorders. The merged company, ... Inc., has commenced operations and incorporates the pipeline ... The Company,s strategy is to build a late-stage ...
Breaking Medicine Technology:Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 2Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 3Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology 4Mallinckrodt Completes Acquisition Of Ikaria 2Mallinckrodt Completes Acquisition Of Ikaria 3Mallinckrodt Completes Acquisition Of Ikaria 4Mallinckrodt Completes Acquisition Of Ikaria 5Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 2Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 3
... Fla., May 26, 2011 Tigris Pharmaceuticals, Inc., today ... Phase 2 clinical trial of AFP-464 (aminoflavone prodrug) with ... cancer patients. Molecular profiling will be used to pre-screen ... which has shown to predict sensitivity to ...
... 26, 2011 Medical Affairs serves as the linchpin for ... a successful market entry of a new product. ... trial strategy & planning, and publication strategy & planning, are ... the activities where organizations turn to Medical Affairs to play ...
Cached Medicine Technology:Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients 2Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients 3Medical Affairs Role in New Product Planning Detailed in Best Practices, LLC Report 2
(Date:4/17/2015)... 17, 2015 In Defense of Christians ... statement: “On Wednesday April 15th, the European Parliament joined ... resolution recognizing the Armenian Genocide, “paying tribute, on the ... one-and-a-half million innocent Armenian victims who perished in the ... the EU for this timely and needed recognition of ...
(Date:4/17/2015)... California (PRWEB) April 17, 2015 At ... Entertainment’s EcoLuxe Lounge and the “Salute to the Oscars” ... luxurious Beverly Hilton Hotel, overlooking the impressive Los Angeles ... were organized by Debbie Durkin, LA’s leading producer of ... Showcasing many of the world’s premier providers of eco-friendly ...
(Date:4/17/2015)... Scientists from the Icahn School ... U.S. and Venezuelan researchers, have discovered the most ... an isolated tribe of Yanomami Amerindians in the ... the Yanomami, previously unexposed to antibiotics or industrialized ... of people living in industrialized countries, and was ...
(Date:4/17/2015)... North Carolina (PRWEB) April 17, 2015 ... Family Dental Care has spent the last four ... dental care, performing procedures ranging from general cleanings to ... host a grand opening at their new office in ... the same services as their Concord office, including denture ...
(Date:4/17/2015)... (PRWEB) April 17, 2015 Ticket Down is a ... their 2015 Summer Tour. , The life of last-minute show announcements ... the popular group perform during the early part of 2015, but ... Will Wait,” “Little Lion Man,” “The Cave,” and “Believe,” will perform ... on June 2 at MCU Park at Coney Island in Brooklyn, ...
Breaking Medicine News(10 mins):Health News:In Defense of Christians Condemns Armenian Genocide 2Health News:In Defense of Christians Condemns Armenian Genocide 3Health News:Choices Recovery Speaks with Dakota Hood of “The Hunger Games” about Addiction in Hollywood 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 3Health News:Mumford and Sons Tickets in Clarkston/Detroit, Raleigh, Columbia/Baltimore, Chicago, Mansfield/Boston, Brooklyn, Calgary and Edmonton Now On Sale 2
... treatment has been found beneficial for boys affected by Duchenne muscular ... steroids helps them to walk on their own for a longer ... ,Duchenne muscular dystrophy occurs in one in 3,500 boys. Symptoms start ... ability to walk between ages nine and 11. There is no ...
... blessing for those women who are on estrogen therapy before the ... of reduction in the risk of Alzheimers disease or dementia. ... estrogen hormone therapy before the age of 65 cut their risk ... on hormone therapy before the age of 65. ...
... anymore for low test scores. According to American research, ... of their conception-which unfortunately they cant help. ... Paul Winchester of Indiana University School of Medicine claimed ... to perform worse than their peers in examinations. ...
... A widely used diabetes drug dramatically boosted the potency of ... cancer cell lines and to mice with tumors, scientists ... chemotherapy agent and the diabetes drug rosiglitazone halted or shrank ... either of the drugs given alone, according to the article ...
... a common condition among the senior lot in Australia. This is ... from an illness or accident. ,A study of ... almost 80 per cent were malnourished. At the same time, the ... were able to reduce their period of stay in the hospital. ...
... so that almost one in five babies rooms sport a television ... babies are sworn friends with the television by the age of ... to a survey by University of Texas researchers, 63 percent of ... switch it on or off at will. On an average babies ...
Cached Medicine News:Health News:Daily Steroids Helpful for Boys Down With Muscular Dystrophy 2Health News:Low Test Scores Of Children Linked To Their Date Of Conception 2Health News:Diabetes Drug Dramatically Boosts Potency of Platinum Chemotherapy 2Health News:Diabetes Drug Dramatically Boosts Potency of Platinum Chemotherapy 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: