BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Tuesday, December 16, 2025
See today's BioWorld
Home » Bridgebio wins accelerated approval for cholangiocarcinoma therapy
To read the full story, subscribe or sign in.

Bridgebio wins accelerated approval for cholangiocarcinoma therapy

May 28, 2021
By Michael Fitzhugh
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
BioWorld Drugs Regulatory Cancer FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 16, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 16, 2025.
  • Businesspeople shaking hands, meeting with cityscape, charts

    Deals and an M&A strengthen end-of-year numbers

    BioWorld
    Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months...
  • Illustration of tau accumulating in a neuron cell.

    ADEL wins $1.04B Sanofi deal for tau-targeting Alzheimer’s drug

    BioWorld
    ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a...
  • PET imaging

    Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints

    BioWorld
    Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing