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 ...

Dec. 18, 2024 — Until now, scientists have been unable to determine how metformin, a Type 2 diabetes medication that lowers blood sugar, works. A study provided direct evidence in mice that it ...

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 FDA's nod is based on late-stage data, which show that treatment with VRTX's Alyftrek enhances patient benefit compared ...

Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...

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

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

Vertex Pharmaceuticals announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...