Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.

combined groups: −5.4 mV (p < 0.001) CF = cystic fibrosis; FEV 1 = forced expiratory volume in 1 second. The classes of cystic fibrosis transmembrane conductance regulator (CFTR) mutations.

The medicine, called trikafta, can treat cystic fibrosis patients who have at least one F508del mutation in the transmembrane conductance regulator gene or a mutation that is responsive to trikafta ...

- In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV 1 and further decreased sweat chloride compared to TRIKAFTA ® - BOSTON, December 20, 2024--(BUSINESS WIRE)--Vertex ...

Alyftrek is Vertex's fifth CFTR modulator to secure FDA approval. It is also under regulatory review in the European Union, the United Kingdom, Canada, Switzerland, Australia and New Zealand. Write to ...

CF is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. An estimated 105,000 people have been diagnosed with CF across 94 countries, according to the CF ...

Vertex Pharmaceuticals has secured two simultaneous US Food and Drug Administration (FDA) approvals for cystic fibrosis (CF) treatments, but both therapies come with boxed warnings for potential ...

Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis ...