Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-03-20FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase) submitted by VIVUS LLC.
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CLINICAL_TRIALS trial_result · 2020-03-13Clinical Trial Update: A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) [Phase 3]
Phase 3 study of VX-659 combination therapy in CF patients with F508del and minimal function mutation completed; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-03-06Clinical Trial Update: A Study of Ataluren in Pediatric Participants With Cystic Fibrosis [Phase 2]
Phase 2 trial update of ataluren in pediatric cystic fibrosis participants completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-02-27Clinical Trial Update: Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis [Phase 2]
Phase 2 trial update for PTI-428 (proteostasis therapeutics) assessing safety, tolerability, pharmacokinetics, and effect in cystic fibrosis…
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FDA approval · 2020-02-20FDA Approved: TOBRAMYCIN INHALATION SOLUTION — Supplemental Application (Dr. Reddy's Laboratories Inc.)
The FDA approved a supplemental application for Dr. Reddy's Tobramycin Inhalation Solution, granting generic approval for this inhaled antib…
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CLINICAL_TRIALS trial_result · 2020-02-11Clinical Trial Update: A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis [Phase 3]
Phase 3 study evaluating TEZ/IVA in children aged 6-11 with cystic fibrosis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-02-05Clinical Trial Update: Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age [Phase 3]
Phase 3 trial evaluating VX-659/TEZ/IVA in children aged 6-11 with cystic fibrosis was terminated; results posted in 2020.
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FDA label_change · 2020-01-28FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase enzyme mix) from VIVUS LLC.
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CLINICAL_TRIALS trial_result · 2020-01-27Clinical Trial Update: A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F) [Phase 3]
Phase 3 study of VX-445 combination therapy in cystic fibrosis patients with F508del/F508del has completed; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-01-18Clinical Trial Update: Single Dose of pGM169/GL67A in CF Patients [Phase 1, Phase 2]
A completed Phase 1/2 clinical trial evaluating a single dose of pGM169/GL67A in cystic fibrosis patients; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-01-13Clinical Trial Update: Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients [Phase 2]
Phase 2 trial update on AeroVanc for persistent MRSA lung infection in cystic fibrosis patients reports efficacy and safety findings.
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CLINICAL_TRIALS trial_result · 2020-01-09Clinical Trial Update: The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis [Phase 2]
Phase 2 trial investigating the effect of oral glutathione on growth parameters in children with cystic fibrosis has completed with results …
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CLINICAL_TRIALS trial_result · 2020-01-06Clinical Trial Update: A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation [Phase 3]
A Phase 3 trial evaluating ivacaftor for cystic fibrosis patients with specific CFTR mutations (3849+10kb C→T or D1152H) has completed with …
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CLINICAL_TRIALS trial_result · 2019-12-30Clinical Trial Update: An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis [Phase 2]
Phase 2 trial update for SPX-101 inhalation solution in cystic fibrosis completed with results posted.
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FDA approval · 2019-12-27FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for Symdeko (tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals.
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FDA approval · 2019-12-09FDA Approved: TOBRAMYCIN INHALATION — Supplemental Application (Prasco, LLC)
The FDA approved a supplemental application for Tobramycin Inhalation by Prasco, LLC, expanding the approved labeling for the product.
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FDA approval · 2019-12-06FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Supplemental Application (Genericus, Inc.)
FDA approved a supplemental application to authorize Genericus, Inc. to market a generic tobramycin inhalation solution PAK.
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CLINICAL_TRIALS trial_result · 2019-12-05Clinical Trial Update: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF) [Phase 3]
Phase 3 trial update assessing pharmacokinetics, safety, and tolerability of VX-661/ivacaftor in pediatric cystic fibrosis patients has comp…
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CLINICAL_TRIALS trial_result · 2019-11-27Clinical Trial Update: BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects [Phase 1]
Phase 1 trial of BI 443651 in healthy volunteers followed by crossover in cystic fibrosis subjects completed with results posted.
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FDA approval · 2019-11-20FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) submitted by Gilead Sciences, Inc.
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CLINICAL_TRIALS trial_result · 2019-11-13Clinical Trial Update: Effect of HFCWO Vests on Spirometry Measurements [NA]
Completed clinical trial assessing the effect of high-frequency chest wall oscillation (HFCWO) vests on spirometry measurements in cystic fi…
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CLINICAL_TRIALS trial_result · 2019-10-29Clinical Trial Update: Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor [Phase 3]
A Phase 3 rollover study evaluating long-term safety and efficacy of lumacaftor in combination with ivacaftor for cystic fibrosis has comple…
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CLINICAL_TRIALS trial_result · 2019-10-24Clinical Trial Update: Telavancin Pharmacokinetics in Cystic Fibrosis Patients [Phase 4]
Phase 4 clinical trial update on telavancin pharmacokinetics in patients with cystic fibrosis.
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FDA approval · 2019-10-21FDA Approved: TRIKAFTA — Original Application (Vertex Pharmaceuticals Incorporated)
FDA approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) as the original application for the treatment of cystic fibrosis. It represents a p…
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CLINICAL_TRIALS trial_result · 2019-10-17Clinical Trial Update: A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F) [Phase 3]
Phase 3 study update for VX-659 combination therapy in cystic fibrosis patients homozygous for F508del (F/F) has completed with results post…