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

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...

Vertex Pharmaceuticals offers promising opportunities in pain management, cystic fibrosis treatments, and a diversified ...

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

The Food and Drug Administration (FDA) has approved Alyftrek ™ (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one ...

The task ahead of Vertex now is to migrate patients already on Trikafta to the new drug. That is supported by data from the ...

The drug will be marketed under the brand name Alyftrek. Post the FDA’s approval, the orally administered Alyftrek has been approved for use in CF patients aged six years and older who have at least ...

This adjustment follows the recent FDA approval of Vertex's cystic fibrosis treatment, Alyftrek, for patients six years and older with specific genetic mutations. Vertex's Alyftrek, a vanzacaftor ...

The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and deutivacaftor, for the treatment of cystic fibrosis (CF) in adults and children ...

Alyftrek is approved as a new treatment for cystic fibrosis, while the FDA expanded the label for Trikafta to include additional genetic mutations.