Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-02-09FDA Approved: PULMOZYME — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Pulmozyme (dornase alfa) from Genentech, Inc.
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CLINICAL_TRIALS trial_result · 2024-02-07Clinical Trial Update: Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis [Phase 4]
Phase 4 clinical trial evaluating vitamin D and prebiotics for intestinal health in cystic fibrosis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2024-01-31Clinical Trial Update: Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis [Phase 1, Phase 2]
Phase 1/2 trial evaluating inhaled AP-PA02 for safety and tolerability in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung …
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CLINICAL_TRIALS trial_result · 2024-01-16Clinical Trial Update: Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy [Phase 3]
Phase 3 study assessing long-term safety and efficacy of VX-445 combination therapy in cystic fibrosis has completed with posted results.
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CLINICAL_TRIALS trial_result · 2023-12-29Clinical Trial Update: Lung Transplant READY Pilot Study [NA]
A completed pilot clinical trial update for the Lung Transplant READY study in cystic fibrosis patients; results posted in December 2023.
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EMA approval · 2023-12-13EMA Authorised: Vantobra (previously Tobramycin PARI) (tobramycin) — Pari Pharma GmbH
EMA has authorised Vantobra (tobramycin) for respiratory tract infections including cystic fibrosis, with Pari Pharma GmbH as the marketing …
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FDA approval · 2023-11-20FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)
FDA approved a supplemental application for VIOKACE (pancrelipase) to update and expand its labeling. The action supports additional indicat…
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FDA approval · 2023-10-27FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, Inc., updating its labeling for exo…
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CLINICAL_TRIALS trial_result · 2023-10-12Clinical Trial Update: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis [Phase 1]
Phase 1 clinical trial updating clearance of 25-hydroxyvitamin D in individuals with cystic fibrosis; results posted after completion.
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CLINICAL_TRIALS trial_result · 2023-10-03Clinical Trial Update: A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF) [Phase 3]
Phase 3 trial results for Trikafta (elexacaftor/tezacaftor/ivacaftor) evaluating cough and physical activity in cystic fibrosis have been co…
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis [Phase 4]
Phase 4 trial comparing US-marketed Creon from a modernized process at an alternate site and with the approved process at a different site i…
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CLINICAL_TRIALS trial_result · 2023-09-13Clinical Trial Update: Ceftolozane/Tazobactam Continuous Infusion for Infective Exacerbations of Cystic Fibrosis and Bronchiectasis [Phase 4]
Phase 4 clinical trial update for continuous infusion ceftolozane/tazobactam in infective exacerbations of cystic fibrosis and bronchiectasi…
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CLINICAL_TRIALS trial_result · 2023-09-07Clinical Trial Update: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation [Phase 3]
Phase 3 trial evaluating safety, pharmacokinetics, and pharmacodynamics of ivacaftor in cystic fibrosis patients under 24 months with Ivacaf…
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele [Phase 2]
A Phase 2 clinical trial update evaluating safety, tolerability, PK and PD in cystic fibrosis patients with at least one G542X allele has be…
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FDA approval · 2023-08-03FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2023-08-03FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2023-08-03FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals. The approval updates the drug’s labeling t…
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FDA approval · 2023-08-03FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2023-08-03FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved Vertex's supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), a cystic fibrosis TRIKAFTA combination t…
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FDA approval · 2023-08-03FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals Incorporated…
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FDA approval · 2023-08-03FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for Symdeko (tezacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated. The action relates …
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CLINICAL_TRIALS trial_result · 2023-08-03Clinical Trial Update: A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF) [Phase 3]
Phase 3 trial assessing the effect of ELX/TEZ/IVA on glucose tolerance in participants with cystic fibrosis has completed with results poste…
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CLINICAL_TRIALS trial_result · 2023-07-28Clinical Trial Update: A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy [Phase 3]
Phase 3 study evaluating long-term safety of elexacaftor combination therapy in cystic fibrosis has completed with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-07-11Clinical Trial Update: A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) [Phase 3]
A Phase 3 study evaluating the safety of the triple combination elexacaftor/tezacaftor/ivacaftor in participants with cystic fibrosis has co…
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FDA approval · 2023-07-10FDA Approved: TOBRAMYCIN INHALATION SOLUTION — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Tobramycin Inhalation Solution submitted by Dr. Reddy's Laboratories Inc.