FiercePharma13d
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.com3d
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.
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 ...
BioSpace13d
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 ...
Hosted on MSN13d
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.
BioPharma Dive3d
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 ...
precisionmedicineonline13d
FDA Approves New 'Vanza Triple' Cystic Fibrosis Drug From Vertex, Expands Label for Trikafta
Alyftrek is approved as a new treatment for cystic fibrosis, while the FDA expanded the label for Trikafta to include additional genetic mutations.
Daily13d
FDA approves Alyftrek once-daily oral combination for cystic fibrosis
The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and ...
How hockey became a lifeline for Gunnar and Boomer Esiason
Throughout Gunnar Esiason's journey with cystic fibrosis, the sport of hockey has always been huge part of his family. See ...
Monthly Prescribing Reference10d
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 ...
Yahoo3d
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
Alyftrek’s approval could also extend Vertex’s market exclusivity in cystic fibrosis, as the drug’s main U.S. patent expires in 2039, two years after Trikafta’s. Vertex priced the therapy ...