Cystic Fibrosis
📧 Sign up to get email alerts when something new happens for Cystic Fibrosis.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2018-08-15FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2018-08-07FDA Approved: ORKAMBI — Original Application (Vertex Pharmaceuticals Incorporated)
The FDA approved ORKAMBI (lumacaftor and ivacaftor) under an original application for the treatment of cystic fibrosis. This marks the first…
-
FDA approval · 2018-07-09FDA Approved: TOBRAMYCIN INHALATION SOLUTION — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Dr. Reddy's Tobramycin Inhalation Solution as an original generic entry (ANDA 207080) for treating cystic fibrosis patients wit…
-
FDA approval · 2018-02-12FDA Approved: SYMDEKO — Original Application (Vertex Pharmaceuticals Incorporated)
FDA approved SYMDEKO (tezacaftor and ivacaftor) as the original application for the treatment of cystic fibrosis. This action represents the…
-
FDA approval · 2018-01-25FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor/ivacaftor) from Vertex Pharmaceuticals Incorporated.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2017-07-31FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved Vertex's supplemental application for KALYDECO (ivacaftor), authorizing changes to the product labeling through a supplemen…
-
FDA approval · 2017-07-31FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA entry concerns a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated, associated with…
-
FDA approval · 2017-07-12FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
The FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc.
-
FDA approval · 2017-05-29FDA Approved: TOBRAMYCIN INHALATION — Supplemental Application (Prasco, LLC)
FDA approved a supplemental application for Tobramycin Inhalation submitted by Prasco, LLC.
-
FDA approval · 2017-05-17FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2017-02-08FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals, resulting in changes to its labeling and/o…
-
FDA approval · 2017-02-08FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals to modify the drug’s labeling, typicall…
-
FDA approval · 2016-12-22FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) from Gilead Sciences, Inc.
-
FDA approval · 2016-12-19FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, Inc.
-
FDA approval · 2016-12-16FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI PODHALER (tobramycin inhalation powder) by Viatris Specialty LLC.
-
FDA approval · 2016-11-18FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Supplemental Application (Genericus, Inc.)
The FDA approved a supplemental application for Tobramycin Inhalation Solution PAK by Genericus, Inc., enabling a generic tobramycin inhalat…
-
FDA approval · 2016-10-06FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA Supplemental Application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc. under BLA022175. The submission pertains to a supp…
-
FDA approval · 2016-09-28FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2016-09-06FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for Orkambi (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2016-08-05FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2016-06-16FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved AbbVie's supplemental application for CREON (pancrelipase), updating its labeling to reflect expanded indications for exocr…
-
FDA approval · 2016-06-08FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.
-
FDA approval · 2016-05-18FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA has approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated. The approval up…
-
FDA approval · 2016-05-16FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase) by VIVUS LLC, expanding labeling/indications related to exocrine pancre…
-
FDA approval · 2016-04-29FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin inhalation solution) from Viatris Specialty LLC. This action updates the produc…