Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-19EMA Authorised: Kaftrio (ivacaftor;tezacaftor;elexacaftor) — Vertex Pharmaceuticals (Ireland) Limited
The EMA authorises Kaftrio (ivacaftor; tezacaftor; elexacaftor) for cystic fibrosis, with Vertex Pharmaceuticals (Ireland) Limited as the ma…
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EMA approval · 2026-08-19EMA Authorised: Alyftrek (deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate) — Vertex Pharmaceuticals (Ireland) Limited
Alyftrek has been authorised in the EU for cystic fibrosis under Vertex Pharmaceuticals, with orphan designation.
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EMA approval · 2026-08-05EMA Authorised: Vantobra (previously Tobramycin PARI) (tobramycin) — Pari Pharma GmbH
EMA authorized Vantobra (tobramycin) for respiratory tract infections including cystic fibrosis; MAH Pari Pharma GmbH; decision date 15/07/2…
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EMA approval · 2026-07-31EMA Authorised: Kaftrio (ivacaftor;tezacaftor;elexacaftor) — Vertex Pharmaceuticals (Ireland) Limited
EMA authorised Kaftrio (ivacaftor; tezacaftor; elexacaftor) for cystic fibrosis, with orphan medicine designation.
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EMA approval · 2026-07-22EMA Authorised: Orkambi (Lumacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited
Orkambi (lumacaftor/ivacaftor) has been authorised by EMA for cystic fibrosis.
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EMA approval · 2026-03-30EMA Authorised: Alyftrek (deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate) — Vertex Pharmaceuticals (Ireland) Limited
EMA authorised Alyftrek, a triple combination cystic fibrosis medicine (deutivacaftor/tezacaftor/vanzacaftor calcium dihydrate) by Vertex Ph…
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FDA approval · 2026-03-27FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals, resulting in updated la…
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FDA approval · 2026-03-27FDA Approved: ALYFTREK — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ALYFTREK (a triple combination of vanzacaftor, tezacaftor, and deutivacaftor) from Vertex Ph…
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FDA approval · 2026-03-27FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA processed/approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals In…
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EMA approval · 2026-03-19EMA Authorised: Kaftrio (ivacaftor;tezacaftor;elexacaftor) — Vertex Pharmaceuticals (Ireland) Limited
The EMA authorised Kaftrio, a fixed-dose triple combination of ivacaftor, tezacaftor and elexacaftor, for cystic fibrosis, with orphan desig…
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FDA approval · 2026-03-17FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. The action updates the pr…
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FDA approval · 2026-03-17FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2026-03-17FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated. The approv…
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FDA approval · 2026-03-17FDA 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 · 2026-03-17FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor/ivacaftor) by Vertex Pharmaceuticals.
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FDA approval · 2026-03-17FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approves a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2026-03-17FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for Symdeko (tezacaftor and ivacaftor) submitted by Vertex Pharmaceuticals.
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FDA approval · 2026-03-17FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI, the lumacaftor/ivacaftor combination manufactured by Vertex Pharmaceuticals Incorporate…
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EMA approval · 2026-03-09EMA Authorised: Cayston (aztreonam lysine) — Gilead Sciences Ireland UC
EMA authorised Cayston (aztreonam lysine) from Gilead Sciences Ireland UC for use in cystic fibrosis and related respiratory tract infection…
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EMA approval · 2026-02-17EMA Authorised: Bronchitol (mannitol) — Pharmaxis Europe Limited
The EMA authorised Bronchitol (mannitol) for cystic fibrosis, marking EU approval with Pharmaxis Europe Limited as the marketing authorizati…
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EMA approval · 2025-12-11EMA Authorised: Tobi Podhaler (tobramycin) — Viatris Healthcare Limited
EMA authorised Tobi Podhaler (tobramycin) for cystic fibrosis and respiratory tract infections; the marketing authorisation holder is Viatri…
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EMA approval · 2025-12-08EMA Authorised: Symkevi (tezacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited
The EMA authorised Symkevi (tezacaftor and ivacaftor) for cystic fibrosis. It has orphan medicine status.
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EMA approval · 2025-10-30EMA Authorised: Orkambi (Lumacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited
The European Medicines Agency authorised Orkambi (lumacaftor/ivacaftor) for cystic fibrosis, with Vertex Pharmaceuticals (Ireland) Limited a…
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FDA approval · 2025-09-25FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated. This a…
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FDA approval · 2025-09-25FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) from Vertex Pharmaceuticals, updating its regulatory…