Vertex secures two FDA wins for cystic fibrosis

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.
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 chalked up a win in its specialty area of cystic fibrosis. | The FDA has approved Vertex’s Alyftrek,
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 progressive genetic disease, the company said on Friday, expanding its dominance in the market for cystic fibrosis.
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 in 2023. It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic.
Vertex drug for cystic fibrosis wins approval
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! This is our last
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 F508del mutation or another responsive mutation in the CFTR gene.
BX-004 by BiomX for Cystic Fibrosis: Likelihood of Approval
BX-004 is under development for the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis and resistant pseudomonas aeruginosa infections. It is administered as inhalational formulation. The drug candidate comprises of cocktail of natural phages developed based on BOLT (Bacteriophage Lead to Treatment) platform.
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 patients eligible for its drugs and likely boosting its own future revenue.
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Vertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people with cystic fibrosis (CF) aged six years and above. The drug will be marketed under the brand name Alyftrek.
WCBI21h
Heda Lab at MUW is furthering Cystic Fibrosis research
A $42,000 grant from NASA and INBRE will further CF research, through a collaborative effort spanning to India and the United Kingdom.
BlackDoctor7d
Living With Cystic Fibrosis: 5 Everyday Habits That Can Change It ALL
Whether you are dealing with severe consequences of cystic fibrosis or want to get ahead the symptoms, these tips will help.
Healthline4d
What Medical Procedures Are Used for Cystic Fibrosis (CF)?
Cystic fibrosis (CF) is a genetic condition that leads to the production of thick, sticky mucus, which can cause complications in multiple organs, including the sinuses, lungs, intestines ...
STAT21h
We wish we’d written that: STAT staffers share their favorite stories of 2024
In STAT's "jealousy list" for 2024, STAT staffers explain what makes a selection of stories they read in other publications ...
First Person In The UK To Have Her Major Organs Transplanted, Dies; Know All About Cystic Fibrosis She Was Born With
Allison Angell, the first person in the UK to have all of her major organs transplanted, has died aged 46—more than a decade ...
Daily3d
Azithromycin therapy shows positive effect on lung perfusion in infants with cystic fibrosis, finds research
A new study published in the Journal of Cystic Fibrosis found that infants with cystic fibrosis who get azithromycin exhibit ...