According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.

The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late Friday.

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...

Different genetic mutations cause different problems with this particular protein -- so CFTR modulators generally don't work on every CF case. But Vertex's newest blockbuster, Trikafta -- approved in ...

The medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...

It builds on the success of Trikafta by covering all mutations included in its label, along with an additional 31 CF-causing mutations. Trikafta was initially approved in 2019 for patients aged 12 ...

As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has chalked up a win in its specialty area of cystic fibrosis. The FDA has ...

The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and deutivacaftor, for the treatment of cystic fibrosis (CF) in adults ...

generic versions of Trikafta, a particularly effective triple-combination treatment for the disease, which causes the body to produce thick, sticky mucus that damages the lungs and other organs.

Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to <12 years and less than 30kg: morning dose of elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg ...