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 ...

The approval also helps shield from erosion of sales when Trikafta loses its patent, said William Blair analyst Myles Minter ahead of the decision. Cystic fibrosis is an inherited disease in which ...

The Phase 3 studies in people with CF ages 12 years and older met their primary endpoint (non-inferiority on absolute change from baseline in ppFEV 1 compared to TRIKAFTA) and all key secondary ...

Doug’s heart pounded when he realized what was happening. Then instinct took over. Doug kept taking pictures, at a shutter speed of one eight-thousandth of a second, capturing an image that ...

George Condo’s new exhibit, titled Pastels, will be split across two galleries: Hauser & Wirth’s SoHo location and Sprüth Magers on the Upper East Side. This two-part show centered around the ...

Taking to her Instagram on Tuesday, Priyanka posted a bunch of pictures, as the family began their Christmas celebrations. (Also Read | Priyanka Chopra enjoys ATV ride in Jeddah; wears Nick Jonas ...