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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
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