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 ...

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

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

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 ...

After Vertex Pharmaceuticals (VRTX) announced early FDA approval of Alyftrek in cystic fibrosis ahead of a PDUFA deadline on January 2, ...

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 ...

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 ...

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 ...

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 ...