Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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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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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.
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FDA approval · 2023-05-03FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated. The approval approves changes…
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FDA approval · 2023-05-03FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2023-04-26FDA Approved: TRIKAFTA — Original Application (Vertex Pharmaceuticals Incorporated)
The FDA approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) as an original application for cystic fibrosis, representing a pivotal triple-c…
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FDA approval · 2023-04-26FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2023-04-10FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Supplemental Application (Genericus, Inc.)
FDA approved a supplemental application to Genericus, Inc. for TOBRAMYCIN INHALATION SOLUTION PAK, a generic version of tobramycin inhalatio…
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FDA approval · 2023-02-10FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Supplemental Application (Genericus, Inc.)
The FDA approved a supplemental application for Tobramycin Inhalation Solution PAK from Genericus, Inc., enabling its marketing as a supplem…
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FDA approval · 2023-02-10FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin) submitted by Viatris Specialty LLC.
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FDA approval · 2023-02-10FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI Podhaler (tobramycin) submitted by Viatris Specialty LLC.
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FDA approval · 2023-02-10FDA Approved: TOBRAMYCIN INHALATION — Supplemental Application (Prasco, LLC)
The FDA approved a supplemental application from Prasco, LLC for Tobramycin Inhalation, authorizing a supplemental approval of a generic inh…
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FDA approval · 2022-09-28FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., approving changes to the product's labeling. P…
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FDA approval · 2022-09-02FDA 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 · 2022-09-02FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor/ivacaftor) from Vertex Pharmaceuticals.
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FDA approval · 2021-10-04FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated. The ap…
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FDA approval · 2021-07-13FDA Approved: TOBRAMYCIN — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for Tobramycin filed by Gland Pharma Limited.
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FDA approval · 2021-06-08FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2021-04-26FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
The FDA approved a supplemental application for Pancreaze (pancrelipase) from VIVUS LLC, updating its labeling and/or indications.
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FDA approval · 2020-12-21FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) filed by Vertex Pharmaceuticals Incorporated. The action authorizes cha…
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FDA approval · 2020-12-21FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for Symdeko (tezacaftor and ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2020-12-21FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.