Neonatal Respiratory Distress Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-10-10FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)
The FDA approved a supplemental application for Curosurf (poractant alfa) from Chiesi USA, Inc., updating the product labeling as part of a …
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CLINICAL_TRIALS trial_result · 2014-06-02Clinical Trial Update: Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial [Phase 1, Phase 2]
A completed Phase 1/2 randomized crossover pilot trial evaluating the feasibility of mid-frequency ventilation in newborns with neonatal res…
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FDA approval · 2014-03-11FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
The FDA approved a supplemental application for INFASURF (calfactant) submitted by ONY Biotech Inc., approving labeling changes and/or expan…
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CLINICAL_TRIALS trial_result · 2014-03-10Clinical Trial Update: Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants [Phase 4]
This Phase 4 trial compared nasal CPAP versus nasal IMV for early rescue surfactant treatment in preterm infants with neonatal respiratory d…
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FDA approval · 2014-02-12FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)
The FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc. This action represents a supplementa…
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CLINICAL_TRIALS trial_result · 2014-01-07Clinical Trial Update: The Effect of Maternal and Neonatal Vitamin D Levels on Respiratory Distress Syndrome in Preterm Infants
Completed clinical trial assessing the relationship between maternal and neonatal vitamin D levels and the risk of neonatal respiratory dist…
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CLINICAL_TRIALS research · 2014-01-06Clinical Trial Update: Urine NT-ProBNP in Neonatal Respiratory Distress
This update covers a clinical trial evaluating urine NT-ProBNP as a biomarker in neonates with neonatal respiratory distress.
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FDA label_change · 2013-12-23FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
FDA approved a supplemental application for INFASURF (calfactant) by ONY Biotech Inc., likely updating product labeling.
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FDA approval · 2013-10-18FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
The FDA approved a supplemental application for INFASURF (calfactant) from ONY Biotech Inc., updating the product labeling. Calfactant is us…
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FDA approval · 2013-06-12FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for SURVANTA (beractant) by AbbVie.
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CLINICAL_TRIALS trial_result · 2013-06-12Clinical Trial Update: Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants [Phase 3]
Follow-up at school-age of children who participated in the efficacy study of inhaled nitric oxide for premature infants.
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FDA approval · 2013-04-15FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)
FDA approved a supplemental application for Curosurf (poractant alfa) held by Chiesi USA, Inc.
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FDA approval · 2013-04-10FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc., updating the regulatory status of the product…
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CLINICAL_TRIALS trial_result · 2013-02-11Clinical Trial Update: Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome [NA]
Completed clinical trial evaluating non-invasive ventilation for neonatal respiratory distress syndrome; results posted in 2013.
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CLINICAL_TRIALS trial_result · 2012-07-19Clinical Trial Update: Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks [NA]
A completed clinical trial evaluated surfactant administration during spontaneous breathing with CPAP in extremely premature infants under 2…
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CLINICAL_TRIALS trial_result · 2012-04-27Clinical Trial Update: Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration [Phase 3]
Phase 3 trial evaluating antenatal steroid administration for prevention of neonatal respiratory distress syndrome has completed.
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FDA approval · 2011-07-01FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
The FDA approved a supplemental application for INFASURF (calfactant) from ONY Biotech.
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CLINICAL_TRIALS trial_result · 2010-06-09Clinical Trial Update: Antenatal Corticoid Therapy for Late Preterm Babies [NA]
A clinical trial evaluating antenatal corticosteroid therapy for late preterm infants has completed, assessing neonatal respiratory outcomes…
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CLINICAL_TRIALS trial_result · 2010-05-07Clinical Trial Update: Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA) [NA]
A randomized controlled trial evaluating surfactant administration by a laryngeal mask airway in newborns with respiratory distress syndrome…
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FDA label_change · 2009-12-10FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)
FDA approved a supplemental application for INFASURF (calfactant) submitted by ONY Biotech Inc. The action likely updates the product's labe…
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FDA approval · 2009-01-12FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc. Beractant is used to treat neonatal respirator…
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FDA approval · 2008-09-26FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)
FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc.