The Food and Drug Administration signed off on Vertex Pharmaceuticals' next-generation triple drug for cystic fibrosis late ...
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 medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...
Vertex Pharmaceuticals announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...
The approval is based on data from a comprehensive late-stage program, which showed that treatment with once-daily Alyftrek enhanced patient benefit compared to Vertex’s blockbuster CF drug ...
Vertex Pharmaceuticals offers promising opportunities in pain management, cystic fibrosis treatments, and a diversified ...
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 ...
After Vertex Pharmaceuticals (VRTX) announced early FDA approval of Alyftrek in cystic fibrosis ahead of a PDUFA deadline on January 2, ...
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 has approved Vertex’s Alyftrek, a once-daily triple combination for the treatment of cystic fibrosis in people 6 years and older who have mutations that are amenable to the therapy ...
Vertex Announces US FDA Approval of ALYFTREKâ„¢, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis ...