FDA Determines Regulatory Review Period for Alyftrek
February 13, 2026
February 13, 2026
WASHINGTON, Feb. 13 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced that it has completed the determination of the regulatory review period for the human drug product Alyftrek. This action follows an application submitted to the U.S. Department of Commerce Patent and Trademark Office for a patent term extension.
Alyftrek, a combination of vanzacaftor, tezacaftor and deutivacaftor, is approved to treat cystic fibrosis in patients age . . .
Alyftrek, a combination of vanzacaftor, tezacaftor and deutivacaftor, is approved to treat cystic fibrosis in patients age . . .