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Research | CFTR Modulators | Drug Pipeline CF Foundation Celebrates FDA Approval of Triple Combination

The U.S. Food and Drug Administration has approved the use of the triple-combination modulator elexacaftor/tezacaftor/ivacaftor (Trikafta™) for people with cystic fibrosis ages 12 and older who have at least one copy of the F508del mutation.

| 3 min read
Research | CFTR Modulators | Drug Pipeline Cystic Fibrosis Foundation statement on FDA approval of TRIKAFTA, the first triple combination therapy for the most common CF mutation

This medicine represents the single greatest therapeutic advancement in the history of CF, offering a treatment for the underlying cause of the disease that could eventually benefit more than 90 percent of people with CF.  

| 3 min read
Drug Pipeline ICER Posts Draft Scoping Document for Assessment of Triple Combination Therapy

The Institute for Clinical and Economic Review (ICER) recently posted a draft scoping document to outline their planned assessment of the clinical effectiveness and value of the triple combination (also known as elexacaftor/tezacaftor/ivacaftor). The document is open for public comment through October 21.

| 2 min read
Research | Drug Pipeline FDA Approves Symdeko® for Children Ages 6 to 11

The U.S. Food and Drug Administration has approved the use of tezacaftor/ivacaftor (Symdeko®) for children with cystic fibrosis ages 6 to 11 with specific mutations.

| 2 min read
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