pharmaphorum1d
FDA approves flurry of drugs ahead of holiday season
The task ahead of Vertex now is to migrate patients already on Trikafta to the new drug. That is supported by data from the ...
Monthly Prescribing Reference2d
Alyftrek Gets FDA Approval for Cystic Fibrosis
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 ...
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 ...
precisionmedicineonline2d
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.
BioSpace2d
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 ...
Vertex Pharmaceuticals: Alyftrek Is An 'Accretive Opportunity' On Top- And Bottom-Lines, Says Bullish Analyst
Vertex Pharmaceuticals announced FDA approval for Alyftrek, which expands the company's CF franchise to address around 6,000 ...
FiercePharma2d
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 ...
STAT2d
Vertex drug for cystic fibrosis wins approval
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Vertex black box warning for Alyftrek ‘somewhat a surprise,’ says Barclays
After Vertex Pharmaceuticals (VRTX) announced early FDA approval of Alyftrek in cystic fibrosis ahead of a PDUFA deadline on January 2, ...
The Pharma Letter3d
Vertex nabs FDA approval for Alyftrek and Trikafta
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations.
Daily3d
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 ...