FiercePharma11d
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
clinicaladvisor.com1d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
GlobalData on MSN11d
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
Cystic Fibrosis Foundation14d
FDA Approves Trikafta for 94 Additional Rare CFTR Mutations
The U.S. Food and Drug Administration (FDA) today approved the expansion of Trikafta (elexacaftor/tezacaftor/ivacaftor) to ...
BioSpace11d
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...
Zacks.com on MSN11d
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
The FDA's nod is based on late-stage data, which show that treatment with VRTX's Alyftrek enhances patient benefit compared ...
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
Monthly Prescribing Reference8d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to <12 years and less than 30kg: morning dose of elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg ...
Vertex' Trikafta Gets Expanded FDA Approval For Cystic Fibrosis Treatment
Vertex Pharmaceuticals (VRTX) said Friday the U.S. Food and Drug Administration expanded its approval of a cystic fibrosis treatment, ...
BioPharma Dive1d
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
US FDA approves Vertex Pharma's triple combo cystic fibrosis treatment
The U.S. Food and Drug Administration has approved Vertex Pharmaceuticals' next-generation treatment for a rare and ...