The FDA on Fri­day is­sued two si­mul­ta­ne­ous cys­tic fi­bro­sis ap­provals for Ver­tex Phar­ma­ceu­ti­cals but in­clud­ed high-lev­el safe­ty warn­ings for both.

Separately, the FDA expanded the indication for Vertex's Trikafta on Friday to include cystic fibrosis patients with additional genetic variants. The FDA initially approved Trikafta in 2019 for ...

TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR) ...

Vertex Pharmaceuticals (VRTX) announced the U.S. Food and Drug Administration has approved the expanded use of Trikafta for the treatment of people with cystic fibrosis ages 2 and older who have ...

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA ® (elexacaftor ...

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.

After its investigation, the Commission secured Vertex's commitment to keep Trikafta available in South Africa under Section 21, allowing unregistered drug sales. The Commission accepts Vertex's ...

South Africans living with cystic fibrosis, a rare and life-threatening genetic condition, have welcomed improved access to essential medication following an agreement between the Competition ...