Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-25FDA Approved: ALYFTREK — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2025-09-25FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2025-09-25FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA supplemental approval for Orkambi (lumacaftor and ivacaftor) by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2025-09-25FDA 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 · 2025-09-25FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA has approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals.
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FDA approval · 2025-09-25FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved Vertex's supplemental application for SYMDEKO (tezacaftor and ivacaftor). The approval updates the product labeling.
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EMA approval · 2025-08-04EMA Authorised: Kalydeco (ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited
The EMA authorised Kalydeco (ivacaftor) for cystic fibrosis under accelerated assessment in the European Union. The decision date was 04/04/…
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EMA approval · 2025-06-20EMA Authorised: Colobreathe (Colistimethate sodium) — Essential Pharma Limited
The EMA authorised Colobreathe, a colistimethate sodium inhalation product for cystic fibrosis, with Essential Pharma Limited as the marketi…
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FDA approval · 2025-05-22FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2025-05-22FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved Vertex's supplemental application for KALYDECO (ivacaftor), updating its labeling for use in cystic fibrosis.
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EMA approval · 2025-04-09EMA Authorised: Quinsair (levofloxacin) — Chiesi Farmaceutici S.p.A
The European Medicines Agency has authorised Quinsair (inhaled levofloxacin) by Chiesi Farmaceutici for use in cystic fibrosis and related r…
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FDA approval · 2025-02-12FDA Approved: ACETYLCYSTEINE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for acetylcysteine from Somerset Therapeutics, LLC, granting approval for a generic acetylcysteine pro…
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FDA approval · 2024-12-20FDA Approved: ALYFTREK — Original Application (Vertex Pharmaceuticals Incorporated)
The FDA approves ALYFTREK, a triple combination therapy of vanzacaftor, tezacaftor, and deutivacaftor, in an original application for cystic…
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FDA approval · 2024-12-20FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated. The action…
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FDA approval · 2024-12-20FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor) submitted by Vertex Pharmaceuticals, relat…
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FDA approval · 2024-12-13FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals. The action updates/expan…
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FDA approval · 2024-12-13FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated. This action con…
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FDA approval · 2024-02-28FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA approved a supplemental application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc.
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FDA approval · 2024-02-28FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for PANCREAZE, a pancreatic enzyme replacement product, submitted by VIVUS LLC.
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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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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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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.