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

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

Throughout Gunnar Esiason's journey with cystic fibrosis, the sport of hockey has always been huge part of his family. See ...

The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...

Different genetic mutations cause different problems with this particular protein -- so CFTR modulators generally don't work ...

Patients are advised to undergo liver function tests before and during treatment with TRIKAFTA. This approval marks a significant milestone for Vertex Pharmaceuticals in their ongoing efforts to ...

More than 80% of people get hot flashes at some point before or after menopause. Changing hormones are believed to be the cause of hot flashes and other symptoms of menopause, including anxiety, ...

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

The U.S. Food and Drug Administration (FDA) today approved the expansion of Trikafta (elexacaftor/tezacaftor/ivacaftor) to people with cystic fibrosis ages 2 and ...

Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple ...

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 ...