PRE-PEN PLUS, a proposed skin test kit for penicillin allergy by AllerQuest
Read MoreJUL 25 PADAC
Supplemental biologics license application or mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts
Read MoreDEC 10 PADAC-DSRM
Consideration of restrictions on pediatric use of codeine
Read MoreDEC 9 PADAC
Teva's reslizumab for eosinophilic asthma
Read MoreDEC 10 PADAC-DSRM
Consideration of restrictions on pediatric use of codeine
Read MoreDEC 10 PADAC-DSRM
Consideration of restrictions on pediatric use of codeine
Read MoreDEC 9 PADAC
Teva's reslizumab for eosinophilic asthma
Read MoreJUN 11 PADAC
GlaxoSmithKline's mepolizumab to treat patients with severe eosinophilic asthma (12 years & older)
Read MoreJUN 11 PADAC
GlaxoSmithKline's mepolizumab to treat patients with severe eosinophilic asthma (12 years & older)
Read MoreJUN 11 PADAC
GlaxoSmithKline's mepolizumab to treat patients with severe eosinophilic asthma (12 years & older)
Read MoreMAY 12 PADAC
Vertex Pharmaceuticals' lumacaftor/ivacaftor for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Read MoreJUN 11 PADAC
GlaxoSmithKline's mepolizumab to treat patients with severe eosinophilic asthma (12 years & older)
Read MoreMAY 12 PADAC BS
Vertex Pharmaceuticals' lumacaftor/ivacaftor for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Read MoreMAY 12 PADAC
Vertex Pharmaceuticals' lumacaftor/ivacaftor for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Read MoreMAY 12 PADAC
Vertex Pharmaceuticals' lumacaftor/ivacaftor for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Read MoreMAR 19 PADAC-DSRM
GlaxoSmithKline's Breo Ellipta for asthma in patients 12 years of age and older. Focus is on the adequacy of the safety database.
Read MoreMAR 19 PADAC-DSRM
GlaxoSmithKline's Breo Ellipta for asthma in patients 12 years of age and older. Focus is on the adequacy of the safety database.
Read MoreMAR 19 PADAC-DSRM
GlaxoSmithKline's Breo Ellipta for asthma in patients 12 years of age and older. Focus is on the adequacy of the safety database.
Read MoreMAR 19 PADAC-DSRM
GlaxoSmithKline's Breo Ellipta for asthma in patients 12 years of age and older. Focus is on the adequacy of the safety database.
Read MoreOCT 21 PADAC
Vertex's Kalydeco (ivacaftor) for cystic fibrosis with the R117H mutation
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