BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 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, May 12, 2026
See today's BioWorld
Home » Confirmatory trials job one with US accelerated approval
To read the full story, subscribe or sign in.

Confirmatory trials job one with US accelerated approval

Oct. 11, 2023
By Mari Serebrov
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
BioWorld Regulatory U.S. FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 11, 2026.
  • Rendering of a key measles protein targeted by neutralizing human antibodies

    First measles treatment advances as vaccination rates drop

    BioWorld
    Scientists at the La Jolla Institute for Immunology have identified and characterized human antibodies that neutralize the measles virus by blocking its entry...
  • Infensa Bioscience identifies new ASIC blockers

    BioWorld Science
    Infensa Bioscience Pty Ltd. has patented new acid-sensing ion channel 1 (ASIC) blockers potentially useful for the treatment of stroke, among others.
  • Neurology illustration

    Italy’s Angelini pays $4.1B cash for rare disease specialist Catalyst

    BioWorld
    Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash...
  • Circulating sncRNA transcriptome in diabetic kidney disease and SGLT2 inhibitor treatment

    BioWorld Science
    Small noncoding RNAs (sncRNAs), including miRNAs, piRNAs and snoRNAs, can provide further biological insights into the mechanisms of chronic kidney disease (CKD)...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • 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 ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing