The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
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Vertex Secures FDA Approval for New Cystic Fibrosis Drug AlyftrekVertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people ...
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.
The medicine hit its primary endpoint of a decrease in the average daily leg pain intensity as measured by the Numeric Pain ...
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 ...
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
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 ...
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 ...
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