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

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

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 ...

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

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

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

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 US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and ...

ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies - - In head-to-head ...

Findings showed treatment with Alyftrek was noninferior to ELX/TEZ/IVA in absolute change from baseline in ppFEV1 at week 24 in both SKYLINE trials. In both trials, participants received oral ELX ...

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 ...