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Research | Drug Pipeline Application for Triple-Combination Therapy Submitted to the FDA

Vertex Pharmaceuticals Inc. announced today that it submitted a New Drug Application to the U.S. Food and Drug Administration for the approval of the first triple-combination therapy for cystic fibrosis.

| 1 min read
Research | Drug Pipeline Vertex Selects Triple Combination With VX-445 to Submit for FDA Approval

Vertex Pharmaceuticals Inc. today announced that it will pursue FDA approval for the triple-combination therapy VX-445 (elexacaftor) plus tezacaftor/ivacaftor (Symdeko®).

| 3 min read
Research | Drug Pipeline FDA Approves Kalydeco for Infants With CF

The U.S. Food and Drug Administration has approved the use of ivacaftor (Kalydeco®) for children as young as 6 months.

| 2 min read
Drug Pipeline | Research Foundation Awards Up to $5.1 Million for NTM Drug Discovery and Development

The Cystic Fibrosis Foundation awarded up to $5.1 million to TB Alliance to advance a drug discovery program in partnership with Johns Hopkins University. The effort will identify compounds with the potential to treat nontuberculous mycobacteria infections that are increasingly found among people with CF.

| 3 min read
Research | Drug Pipeline New, Positive Results Announced for Triple-Combination Therapy

Today, Vertex released positive preliminary clinical trial results for the potential triple-combination therapy VX-445 plus tezacaftor/ivacaftor (Symdeko®).

| 3 min read
Drug Pipeline CF Foundation Expands Funding Up to $4.5 Million to Talee Bio Inc. to Develop CFTR Mutation-Agnostic Gene Therapy

The Cystic Fibrosis Foundation awarded Talee Bio Inc. up to $4.5 million to develop methods for delivering potential gene therapy treatments to the lungs. 

| 2 min read
Research | Drug Pipeline | Clinical Trials Positive Late Stage Study Results for Next-Generation, Triple-Combination Modulator

Today, Vertex Pharmaceuticals Inc. released the initial Phase 3 clinical trial data for one of two next-generation, triple-combination modulators currently being tested.

| 3 min read
Research | CFTR Modulators | Drug Pipeline FDA Expands Use of Orkambi® to Children With CF Ages 2 to 5

The U.S. Food and Drug Administration approved the use of lumacaftor/ivacaftor (Orkambi®) today for children with cystic fibrosis ages 2 to 5 who have two copies of the F508del mutation.

| 3 min read
Research | Drug Pipeline Drug Shows Promise in Reducing Inflammation in People With Cystic Fibrosis

Celtaxsys Inc. reported promising results today from an early stage clinical trial of a potential anti-inflammatory drug for people with cystic fibrosis.

| 2 min read
Research | Drug Pipeline | Clinical Trials Phase 2 Study Shows Promising Results for Potential Mucus Clearance Drug

A new drug intended to make it easier to clear mucus from the lungs of people with cystic fibrosis showed promising results in a Phase 2 clinical trial. The drug, called SPX-101, blocks the overactive sodium channels that line CF lung cells.

| 2 min read